Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy
|ClinicalTrials.gov Identifier: NCT00966888|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 27, 2009
Last Update Posted : August 12, 2013
RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage II breast cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage II breast cancer who have undergone mastectomy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: standard follow-up care Radiation: radiation therapy||Phase 3|
- Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive standard of care and observation only. After completion of study therapy, patients are followed up twice in the first year, and then annually for up to 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3500 participants|
|Official Title:||Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||June 2010|
Experimental: Arm I
Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: radiation therapy
Chest wall radiotherapy
Active Comparator: Arm II
Patients receive standard of care and observation only.
Procedure: standard follow-up care
- Overall survival
- Acute and late morbidity
- Chest wall recurrence
- Regional recurrence
- Disease-free survival
- Metastasis-free survival
- Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])
- Quality of life
- Cost effectiveness
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966888
|Edinburgh Cancer Centre at Western General Hospital||Recruiting|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Contact: Ian H. Kunkler, MD 44-131-537-2214 firstname.lastname@example.org|
|Royal Infirmary - Castle||Recruiting|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Contact: Peter A. Canney, MD 44-141-211-1160|
|Principal Investigator:||Ian H. Kunkler, MD||Edinburgh Cancer Centre at Western General Hospital|