Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 10:45 PM
Study NCT ID:
NCT00003857
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 636}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local recurrence (e.g., invasive or noninvasive recurrence)', 'timeFrame': 'From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.'}, {'measure': 'Time to distant metastasis', 'timeFrame': 'From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.'}, {'measure': 'Invasive local recurrence', 'timeFrame': 'From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.'}, {'measure': 'Salvage mastectomy rate', 'timeFrame': 'Analysis occurs after all patients have been potentially followed for 5 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer in situ', 'ductal breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '25605856', 'type': 'RESULT', 'citation': 'McCormick B, Winter K, Hudis C, Kuerer HM, Rakovitch E, Smith BL, Sneige N, Moughan J, Shah A, Germain I, Hartford AC, Rashtian A, Walker EM, Yuen A, Strom EA, Wilcox JL, Vallow LA, Small W Jr, Pu AT, Kerlin K, White J. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. J Clin Oncol. 2015 Mar 1;33(7):709-15. doi: 10.1200/JCO.2014.57.9029. Epub 2015 Jan 20.'}, {'pmid': '34406870', 'type': 'DERIVED', 'citation': "McCormick B, Winter KA, Woodward W, Kuerer HM, Sneige N, Rakovitch E, Smith BL, Germain I, Hartford AC, O'Rourke MA, Walker EM, Strom EA, Hopkins JO, Pierce LJ, Pu AT, Sumida KNM, Vesprini D, Moughan J, White JR. Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804. J Clin Oncol. 2021 Nov 10;39(32):3574-3582. doi: 10.1200/JCO.21.01083. Epub 2021 Aug 18."}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast.\n* Compare distant disease-free survival of patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years.\n* Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '26 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis\n\n * Unicentric\n * Lesions ≤ 2.5 cm\n * Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in \\< one third of the involved ducts\n * Inked margins ≥ 3 mm\n * Clinically node negative\n * Non-palpable\n* No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery\n* No bloody nipple discharge\n* No more than 12 weeks since prior final surgery (arm II only)\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 26 and over\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Not pregnant or nursing\n* No active connective tissue disorders (e.g., lupus or scleroderma)\n* No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)\n\nRadiotherapy:\n\n* No prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00003857', 'briefTitle': 'Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ', 'organization': {'class': 'NETWORK', 'fullName': 'Radiation Therapy Oncology Group'}, 'officialTitle': 'Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast', 'orgStudyIdInfo': {'id': 'RTOG-9804'}, 'secondaryIdInfos': [{'id': 'CDR0000067020'}, {'id': 'CAN-NCIC-MA26'}, {'id': 'CALGB-49801'}, {'id': 'NCI-2011-02038', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Observation +/- tamoxifen for 5 years', 'description': 'Observation +/- tamoxifen 20 mg per day for 5 years', 'interventionNames': ['Drug: tamoxifen citrate', 'Procedure: adjuvant therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Radiation therapy +/- tamoxifen for 5 years', 'description': 'Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years', 'interventionNames': ['Drug: tamoxifen citrate', 'Procedure: adjuvant therapy', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'tamoxifen citrate', 'type': 'DRUG', 'armGroupLabels': ['Observation +/- tamoxifen for 5 years', 'Radiation therapy +/- tamoxifen for 5 years']}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Observation +/- tamoxifen for 5 years', 'Radiation therapy +/- tamoxifen for 5 years']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Radiation therapy +/- tamoxifen for 5 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99701', 'city': 'Fairbanks', 'state': 'Alaska', 'country': 'United States', 'facility': 'Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital', 'geoPoint': {'lat': 64.83778, 'lon': -147.71639}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Services Foundation', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': "Saint Joseph's Mercy Cancer Center", 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center - Burbank', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '95926', 'city': 'Chico', 'state': 'California', 'country': 'United States', 'facility': 'Enloe Cancer Center at Enloe Medical Center', 'geoPoint': {'lat': 39.72849, 'lon': -121.83748}}, {'zip': '94524-4110', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Mount Diablo Regional Cancer Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '94533', 'city': 'Fairfield', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Cancer Center', 'geoPoint': {'lat': 38.24936, 'lon': -122.03997}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Washington Township Hospital', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93720-3397', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Saint Agnes Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91346-9600', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Providence Holy Cross Cancer Center', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Medical Center Cancer Services', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'CCOP - Bay Area Tumor Institute', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Radiological Associates of Sacramento Medical Group, Incorporated', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'CCOP - Santa Rosa Memorial Hospital', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'John Muir/Mt. 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C. 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