Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
- Conditions
- Breast Cancer
- Registration Number
- NCT00002851
- Brief Summary
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.
- Detailed Description
OBJECTIVES:
* Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival, disease-free survival, metastasis-free survival, and cause of death in women with resected stage I/II/III breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms.
* Arm I: Patients receive no nodal irradiation.
* Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of 25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery. If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery.
Patients are followed at least yearly after randomization for up to 20 years.
PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 4000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
Ziekenhuis Network Antwerpen Middelheim
🇧🇪Antwerp, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Algemeen Ziekenhuis Sint-Augustinus
🇧🇪Wilrijk, Belgium
Institute of Oncology - Clinical Center University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Instituto de Radiomedicina
🇨🇱Santiago, Chile
Clinica Alemana
🇨🇱Santiago, Chile
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
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