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Trial NCT00003857

Resource URI: http://static.linkedct.org/resource/trials/NCT00003857
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linkedct:brief_title Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
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linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5381>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5569>
linkedct:condition <http://static.linkedct.org/resource/condition/1883>
linkedct:criteria DISEASE CHARACTERISTICS: - Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis - Unicentric - Lesions  2.5 cm - Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in < one third of the involved ducts - Inked margins  3 mm - Clinically node negative - Non-palpable - No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery - No bloody nipple discharge - No more than 12 weeks since prior final surgery (arm II only) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 26 and over Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - No active connective tissue disorders (e.g., lupus or scleroderma) - 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills) Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics
linkedct:description OBJECTIVES: - 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. - Compare distant disease-free survival of patients treated with these regimens. OUTLINE: 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. - Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years. - 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. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 26 Years
linkedct:enrollment 1790 (xsd:int)
linkedct:firstreceived_date November 1, 1999
linkedct:id NCT00003857
rdfs:label Trial NCT00003857
linkedct:lastchanged_date February 6, 2009
linkedct:lead_sponsor_agency Radiation Therapy Oncology Group
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linkedct:nct_id NCT00003857
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linkedct:official_title Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
linkedct:org_study_id CDR0000067020
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linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00003857>
linkedct:phase Phase 3
linkedct:primary_completion_date February 2004
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/11929>
linkedct:secondary_id CALGB-49801
linkedct:secondary_id CAN-NCIC-MA26
linkedct:secondary_id RTOG-9804
linkedct:secondary_id RTOG-DEV-1026
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linkedct:source National Cancer Institute (NCI)
linkedct:start_date December 1999
linkedct:study_design Treatment, Randomized, Active Control
linkedct:study_type Interventional
linkedct:summary 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. PURPOSE: 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.
rdf:type linkedct:trials
linkedct:verification_date July 2006