Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
Recruitment status was Active, not recruiting
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.
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast|
- Local recurrence (e.g., invasive or noninvasive recurrence) [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Time to distant metastasis [ Designated as safety issue: No ]
- Invasive local recurrence [ Designated as safety issue: No ]
- Salvage mastectomy rate [ Designated as safety issue: No ]
|Study Start Date:||December 1999|
|Estimated Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
- 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.
Show 369 Study Locations
|Study Chair:||Beryl McCormick, MD||Memorial Sloan-Kettering Cancer Center|
|Investigator:||Clifford A. Hudis, MD||Memorial Sloan-Kettering Cancer Center|
|Study Chair:||Barbara L. Smith, MD, PhD||Massachusetts General Hospital|
|Study Chair:||Timothy J. Whelan, MD||Margaret and Charles Juravinski Cancer Centre|
|Investigator:||Eileen Rakovitch, MD||Edmond Odette Cancer Centre at Sunnybrook|