Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-11-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-11-30"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2023-08-03"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2023-11-07"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2023-11-30",
      "type": "ACTUAL"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Local Recurrence"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "5 years"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Local recurrence(LR) defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years.\nThe estimated 5-year cumulative incidence of LR will be reported as a percentage of patients expected to experience a LR at 5 years."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Conversion Rate to Mastectomy"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "5 years"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "The conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting BCS; or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Type and Severity of Adverse Effects of Breast-conserving Surgery and Radiation as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Radiation-related Side Effects"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "17 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "Radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site as assessed by NCI CTCAE version 4.0."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "value": "Patient's Perception of Cosmesis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "24 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "value": "Patient's perception of cosmesis will be assessed at their initial post-operative visit as well as 24 months following completion of WBI using the BREAST-Q subscales: satisfaction with breasts, satisfaction with overall outcome, and physical well-being.\nPatients registered after surgery will not partake in the pre-operative assessment but will be asked to complete subsequent cosmesis surveys.\nThe total score for each of these subscales will be determined using the BREAST-Q scoring module (http://www.mskcc.org/mskcc/shared/Breast-Q/scoreBQ.html).\nThe BREAST-Q has multiple domains, and each domain score is obtained by transforming the raw scale item responses with the Q-Score software program.\nEach domain results in an independent score from 0 to 100 (higher scores indicate greater satisfaction or quality of life)."
  },
  {
    "op": "remove",
    "path": "/annotationSection"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "Boughey.Judy@mayo.edu",
          "phone": "507-266-9997",
          "title": "Judy Boughey",
          "organization": "Mayo Clinic"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        }
      },
      "adverseEventsModule": {
        "timeFrame": "Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months.",
        "description": "All patients that were treated and evaluable for adverse events are included in this adverse events summary.\nAll patients that were registered are included in the mortality summary.",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Breast Conservation Surgery and Radiation Therapy",
            "description": "whole breast irradiation",
            "otherNumAtRisk": 251,
            "deathsNumAtRisk": 270,
            "otherNumAffected": 169,
            "seriousNumAtRisk": 251,
            "deathsNumAffected": 9,
            "seriousNumAffected": 8
          }
        ],
        "otherEvents": [
          {
            "term": "Anemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Febrile neutropenia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Heart failure",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Cardiac disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Eye disorders - Other, specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Eye disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Nausea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Upper gastrointestinal hemorrhage",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Edema trunk",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Fatigue",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 20,
                "numAffected": 20
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Localized edema",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 4,
                "numAffected": 4
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Non-cardiac chest pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 9,
                "numAffected": 8
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Breast infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Lung infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Skin infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Urinary tract infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Wound infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 11,
                "numAffected": 9
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Bruising",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Dermatitis radiation",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 146,
                "numAffected": 145
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Postoperative hemorrhage",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Seroma",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 56,
                "numAffected": 50
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Wound dehiscence",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Weight loss",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Hyperglycemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Back pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Joint range of motion decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Musculoskeletal, conn tissue - Oth spec",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Neck pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Pain in extremity",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Paresthesia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Peripheral sensory neuropathy",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Tremor",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Depression",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Insomnia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Breast pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 13,
                "numAffected": 13
              }
            ],
            "organSystem": "Reproductive system and breast disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Reproductive system and breast -Oth spec",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Reproductive system and breast disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Sore throat",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Dry skin",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Erythema multiforme",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Erythroderma",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Pain of skin",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Pruritus",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 6,
                "numAffected": 6
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Skin and subcut tissue disord - Oth spec",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Skin hyperpigmentation",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 8,
                "numAffected": 8
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Skin induration",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Skin ulceration",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Hematoma",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Hypertension",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Hypotension",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Lymphedema",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 15,
                "numAffected": 15
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          }
        ],
        "seriousEvents": [
          {
            "term": "Dermatitis radiation",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Seroma",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Wound dehiscence",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          },
          {
            "term": "Hematoma",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 251,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 12"
          }
        ],
        "frequencyThreshold": "0"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Local Recurrence",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "204",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Breast Conservation Surgery and Radiation Therapy",
                "description": "Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy."
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3.1",
                        "groupId": "OG000",
                        "lowerLimit": "1.3",
                        "upperLimit": "6.4"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "5 years",
            "description": "Local recurrence(LR) defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years.\nThe estimated 5-year cumulative incidence of LR will be reported as a percentage of patients expected to experience a LR at 5 years.",
            "unitOfMeasure": "percentage of participants",
            "dispersionType": "95% Confidence Interval",
            "reportingStatus": "POSTED",
            "populationDescription": "All patients that received protocol therapy and were evaluated for response"
          },
          {
            "type": "SECONDARY",
            "title": "Conversion Rate to Mastectomy",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "198",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Breast Conservation Surgery and Radiation Therapy",
                "description": "<p>Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician&#x27;s discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician&#x27;s discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.&gt;\n&gt;&gt;</p><p>&gt;</p><p>&gt;&gt; therapeutic conventional surgery&gt;</p><p>&gt;&gt;</p><p>&gt;</p><p>&gt;&gt; whole breast irradiation</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "7.1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "5 years",
            "description": "The conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting BCS; or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.",
            "unitOfMeasure": "percentage of patients converted",
            "reportingStatus": "POSTED",
            "populationDescription": "There are only 198 patients in this analysis because it excludes those registered postoperatively"
          },
          {
            "type": "SECONDARY",
            "title": "Type and Severity of Adverse Effects of Breast-conserving Surgery and Radiation as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0",
            "timeFrame": "Up to 30 days post-treatment",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "SECONDARY",
            "title": "Radiation-related Side Effects",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "195",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Breast Conservation Surgery and Radiation Therapy",
                "description": "Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician&#x27;s discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician&#x27;s discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy."
              }
            ],
            "classes": [
              {
                "title": "Grade 1",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "69",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Grade 2",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "74",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Grade 3",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "6",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "17 months",
            "description": "Radiation-related side effects of whole-breast radiation with a boost to 1 large or &gt; 1 lumpectomy site as assessed by NCI CTCAE version 4.0.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "All eligible patients that received radiation therapy."
          },
          {
            "type": "SECONDARY",
            "title": "Patient&#x27;s Perception of Cosmesis",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "216",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Breast Conservation Surgery and Radiation Therapy",
                "description": "Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician&#x27;s discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician&#x27;s discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy."
              }
            ],
            "classes": [
              {
                "title": "Good or excellent (50-100)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "70.6",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Fair (25-50)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "25.7",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Poor (0-25)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3.7",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "24 months",
            "description": "Patient&#x27;s perception of cosmesis will be assessed at their initial post-operative visit as well as 24 months following completion of WBI using the BREAST-Q subscales: satisfaction with breasts, satisfaction with overall outcome, and physical well-being.\nPatients registered after surgery will not partake in the pre-operative assessment but will be asked to complete subsequent cosmesis surveys.\nThe total score for each of these subscales will be determined using the BREAST-Q scoring module (http:&#x2F;&#x2F;www.mskcc.org&#x2F;mskcc&#x2F;shared&#x2F;Breast-Q&#x2F;scoreBQ.html).\nThe BREAST-Q has multiple domains, and each domain score is obtained by transforming the raw scale item responses with the Q-Score software program.\nEach domain results in an independent score from 0 to 100 (higher scores indicate greater satisfaction or quality of life).",
            "unitOfMeasure": "percentage of patients",
            "reportingStatus": "POSTED"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Breast Conservation Surgery and Radiation Therapy",
            "description": "<p>Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician&#x27;s discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician&#x27;s discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.&gt;&gt;\n&gt;&gt; therapeutic conventional surgery&gt;&gt;</p><p>&gt;&gt; whole breast irradiation</p>"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "270"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "204"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "66"
                  }
                ]
              }
            ],
            "dropWithdraws": [
              {
                "type": "Ineligible",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "34"
                  }
                ]
              },
              {
                "type": "Converted to mastectomy",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "14"
                  }
                ]
              },
              {
                "type": "Unable to achieve negative margins",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "2"
                  }
                ]
              },
              {
                "type": "Withdrawal by Subject",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "16"
                  }
                ]
              }
            ]
          }
        ]
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "270",
                "groupId": "BG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "Breast Conservation Surgery and Radiation Therapy",
            "description": "<p>Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician&#x27;s discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician&#x27;s discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.&gt;&gt;\n&gt;&gt; therapeutic conventional surgery&gt;&gt;</p><p>&gt;&gt; whole breast irradiation</p>"
          }
        ],
        "measures": [
          {
            "title": "Age, Continuous",
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "60.5",
                        "groupId": "BG000",
                        "lowerLimit": "40",
                        "upperLimit": "87"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "unitOfMeasure": "years",
            "dispersionType": "FULL_RANGE"
          },
          {
            "title": "Sex: Female, Male",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Female",
                    "measurements": [
                      {
                        "value": "270",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Ethnicity (NIH&#x2F;OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "9",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Not Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "245",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "16",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Race (NIH&#x2F;OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "American Indian or Alaska Native",
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Asian",
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Native Hawaiian or Other Pacific Islander",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Black or African American",
                    "measurements": [
                      {
                        "value": "22",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "White",
                    "measurements": [
                      {
                        "value": "232",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "More than one race",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "11",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          }
        ]
      }
    }
  },
  {
    "op": "add",
    "path": "/documentSection",
    "value": {
      "largeDocumentModule": {
        "largeDocs": [
          {
            "date": "2018-09-11",
            "size": 1148412,
            "label": "Study Protocol and Statistical Analysis Plan",
            "hasIcf": false,
            "hasSap": true,
            "filename": "Prot_SAP_000.pdf",
            "typeAbbrev": "Prot_SAP",
            "uploadDate": "2023-06-15T15:04",
            "hasProtocol": true
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    }
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