This trial is active, not recruiting.

Condition breast cancer
Treatments adjuvant therapy, low-let electron therapy, low-let photon therapy
Phase phase 3
Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Start date July 1996
Trial size 4000 participants
Trial identifier NCT00002851, CDR0000065094, EORTC-10925, EORTC-22922


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Eligibility Criteria

Female participants up to 75 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed unilateral adenocarcinoma of the breast - Stage I/II/III (Tx, T0-3, N0-2) disease in one of the following categories or multifocal tumors if one of the foci is in agreement with the following: - Centrally or medially located with any lymph node status - Central location defined as underlying the areola - Medial location defined as at least partial involvement of upper or lower medial quadrant of breast - Externally located with axillary node involvement - Prior mastectomy or breast-conserving surgery and axillary dissection required - Sentinel node procedure as axillary intervention without further axillary surgery is allowed - No prior internal mammary chain dissection - No upper inner lesion treated with breast-conserving surgery that precludes sparing of internal mammary lymph node chain from radiotherapy volume - Decision at radiation oncologist's discretion - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 75 and under Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No prior cardiac disease Other: - No prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - Concurrent enrollment in other randomized trials allowed

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).