Status:
UNKNOWN
Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly ...
Detailed Description
OBJECTIVES: * To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence. OU...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Resectable, unilateral disease
- T1-3, N0-1, M0 disease
- Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer
- Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
- Age 18-49 years
- Tumor size \> 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
- Tumor of any size treated by primary medical therapy
- Grade III disease
- Minimum microscopic margin of noncancerous tissue \< 5 mm (excluding deep margin if at deep fascia)
- Lymphovascular invasion
- Axillary node positive
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior mastectomy
- No concurrent chemotherapy except primary or sequential chemotherapy
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT00818051
Start Date
August 1 2008
Last Update
January 7 2011
Active Locations (1)
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1
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT