Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
|ClinicalTrials.gov Identifier: NCT00002851|
Recruitment Status : Unknown
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 29, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: adjuvant therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Official Title:||PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER|
|Study Start Date :||July 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002851
Show 48 Study Locations
|OverallOfficial:||Walter F. Van den Bogaert, MD, PhD||University Hospital, Gasthuisberg|
|OverallOfficial:||H. Struikmans, MD, PhD||Medisch Centrum Haaglanden Westeinde|
|OverallOfficial:||Alain Fourquet, MD||Institut Curie|
|OverallOfficial:||Harry Bartelink, MD, PhD||The Netherlands Cancer Institute|