Status:
COMPLETED
Randomized Boost Versus no Boost Irradiation of Early Breast Cancer
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Breast Cancer
Eligibility:
FEMALE
Up to 70 years
Phase:
PHASE3
Brief Summary
Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase III trial is studying the effect of an extra dose of radiation therapy (Boost dose) after breast conserving su...
Detailed Description
This is a randomized study. Patients are stratified by participating institution, menopausal status, clinical tumor size, nodal status, presence of Ductal Carcinoma In Situ, age, and resection margin ...
Eligibility Criteria
Inclusion
- Histologically documented invasive adenocarcinoma (any subtype) of the breast with clinical stage T1-2 (0-5 cm) and pathologic stage N0-1, M0 disease
- Lumpectomy with 1-2 cm margin required within 9 weeks of initiation of protocol radiotherapy
- Axillary dissection required for premenopausal patients and recommended for postmenopausal patients (Irradiation of clinically negative axilla is an acceptable alternative to axillary dissection in postmenopausal patients)
Exclusion
- Residual microcalcification on postoperative mammogram
- Gross residual disease in the breast (re-excision allowed if there is gross residual disease after first surgical procedure)
- Multiple foci of tumor in more than 1 quadrant
- Previous or concurrent malignant tumor in contralateral breast
- In situ carcinoma of the breast, without invasive tumor
- Tumorectomy performed more than 9 weeks before the start of radiotherapy in cases where no adjuvant chemotherapy is given and more than 6 months before the start of radiotherapy if chemotherapy is given
- Previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
- Concurrent pregnancy or lactation
- Eastern Cooperative Oncology Group performance scale more than 2
Key Trial Info
Start Date :
May 1 1989
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02295033
Start Date
May 1 1989
Last Update
November 19 2014
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