Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Walter F. Van den Bogaert

H. Struikmans

Alain Fourquet, MD

Harry Bartelink

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002851
Information obtained from ClinicalTrials.gov on December 22, 2011

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