Status:
COMPLETED
Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation dire...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer. Secon...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma of the breast
- Invasive or in-situ disease
- Stage Tis, T1, or T2 (AJCC stage 0, I, or II) disease
- Treated with breast-conserving surgery within the past 8 weeks
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Not specified
- Menopausal status
- Not specified
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
- No active systemic lupus
- No history of scleroderma
- No other medical or psychiatric condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No more than 6 weeks since prior adjuvant systemic chemotherapy
- No concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy to the breast
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00084539
Start Date
November 1 2003
Last Update
March 3 2016
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497