Status:
ACTIVE_NOT_RECRUITING
Breast-Conserving Surgery and Whole-Breast Radiation Therapy With or Without Additional Radiation Therapy to the Tumor in Treating Women With Ductal Carcinoma in Situ (BONBIS)
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
NA
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether whole-b...
Detailed Description
OBJECTIVES: Primary * Estimate and compare local recurrence-free survival of women with ductal breast carcinoma in situ (DCIS) treated with breast-conserving surgery followed by whole breast irradia...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ of the breast
- No invasive component
- No clinically palpable lymph node or presence of tumor cells in the sentinel lymph node (if done)
- No local recurrence of a primary breast cancer
- No multicentric or multifocal tumors not suitable for conservative surgery R0 with a margin ≥ 1 mm
- Has undergone bilateral mammography within 6 months before randomization
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 5 years
- Not pregnant
- Available for long-term follow up
- No history of in situ carcinoma in the contralateral breast
- No history of another cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No uncontrolled cardiac, renal, or pulmonary disease
- No uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma)
- No HIV positivity
- Affiliated with the social health system
- No psychological, familial, sociological, or geographical situations that preclude compliance with study treatment and follow up
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent participation in another therapeutic trial (participation in epidemiologic studies is allowed)
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2029
Estimated Enrollment :
2004 Patients enrolled
Trial Details
Trial ID
NCT00907868
Start Date
November 1 2008
End Date
October 1 2029
Last Update
December 1 2025
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298