Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast

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    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2016-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "TERMINATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2017-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2016-07-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2016-07-04"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "The pre-specified stopping boundary was reached."
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast."
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<ul><li>Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone.\nThe purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates.</li><li>Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist.\nMammograms of the affected breast will be obtained every 6 months for 5 years and then annually.\nMammograms of the unaffected breast will be performed annually.</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/allocation",
    "value": "NA"
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  {
    "op": "remove",
    "path": "/protocolSection/designModule/designInfo/primaryPurpose"
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  {
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    "value": 158
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Observation (omission of RT)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Wide excision of DCIS; no radiotherapy (RT)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Other: Observation"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/type",
    "value": "OTHER"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Observation"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Observation (omission of RT)"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames"
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    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Patients must have high quality mammogram including magnification views of the area containing suspicious calcifications.</li><li>A specimen radiograph is required.\nIf the specimen radiograph does not assure removal of all suspicious microcalcifications, a post-operative mammogram showing removal of all suspicious calcifications is required.</li><li>The clinical extent of DCIS must be less than or equal to 2.5 cm.</li><li>Grade 1 or 2 DCIS; patients with lobular carcinoma-in-situ (LCIS) in addition to DCIS in the breast are eligible.\nNegative margins are not required on the LCIS.</li><li>Patients must undergo a wide excision.\nA re-excision after the initial biopsy might be needed.\nComplete resection of the area of DCIS with a histologic margin of at least 1 cm must be achieved.</li><li>Patients must be enrolled on this protocol within 3 months of the last surgical procedure.</li></ul><p>Exclusion Criteria:</p><ul><li>Patients with invasive carcinoma including microinvasive disease</li><li>Carcinoma found in the sampled lymph nodes if axillary dissection is done</li><li>Patients with nipple discharge</li><li>Patients with adjuvant chemotherapy or Tamoxifen</li><li>Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.</li><li>Patients with a history of ipsilateral or contralateral breast carcinoma or DCIS or simultaneous bilateral DCIS.</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/0/facility",
    "value": "Dana-Farber Cancer Institute"
  },
  {
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    "value": {
      "references": [
        {
          "pmid": "16461781",
          "type": "RESULT",
          "citation": "Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200&#x2F;JCO.2005.02.9975. Epub 2006 Feb 6."
        },
        {
          "pmid": "24346130",
          "type": "RESULT",
          "citation": "Wong JS, Chen YH, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Smith BL, Troyan SL, Harris JR. Eight-year update of a prospective study of wide excision alone for small low- or intermediate-grade ductal carcinoma in situ (DCIS). Breast Cancer Res Treat. 2014 Jan;143(2):343-50. doi: 10.1007&#x2F;s10549-013-2813-6. Epub 2013 Dec 18."
        }
      ]
    }
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      "ipdSharing": "NO"
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