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Phase III Randomized Study of Whole Breast Radiotherapy Versus Observation With or Without Optional Tamoxifen in Women With Good-Risk Ductal Carcinoma In Situ of the Breast
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Treatment | Closed | 26 and over | RTOG-9804 CAN-NCIC-MA26, CALGB-49801, RTOG-DEV-1026, RTOG-98-04, NCT00003857, MA26 |
Special Category:
CTSU trial 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.
Entry 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:
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: - No other concurrent hormonal therapy (e.g., raloxifene,
hormone replacement therapy, or birth control pills)
Radiotherapy: Surgery: - See Disease Characteristics
Patient Characteristics:
Age: Sex: Menopausal status: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: 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
Expected Enrollment 1790A total of 1,790 patients will be accrued for this study within 6 years. Outcomes Primary Outcome(s)Local recurrence (e.g., invasive or noninvasive recurrence)
Secondary Outcome(s)Overall survival Time to distant metastasis Invasive local recurrence Salvage mastectomy rate
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.
Trial Contact Information
Trial Lead Organizations Radiation Therapy Oncology Group | | | Beryl McCormick, MD, Protocol chair | | Ph: 212-639-6828; 800-525-2225 |
| | Clifford Hudis, MD, Protocol co-chair | | Ph: 646-888-4551; 800-525-2225 |
| |
Cancer and Leukemia Group B | | | Barbara Smith, MD, PhD, Protocol chair | | | |
NCIC-Clinical Trials Group | | | Timothy Whelan, MD, Protocol chair | | Ph: 905-387-9711 ext. 64509 |
| | Eileen Rakovitch, MD, Protocol co-chair | | | |
Registry Information | | Official Title | | Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast | | Trial Start Date | | 1999-12-13 | | Trial Completion Date | | 2004-02-24 (estimated) | | Registered in ClinicalTrials.gov | | NCT00003857 | | Date Submitted to PDQ | | 1999-04-07 | | Information Last Verified | | 2006-07-13 | | NCI Grant/Contract Number | | CA21661 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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