Status:
COMPLETED
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
48-120 years
Phase:
NA
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility of intraoperative partial breast radiotherapy prior to surgical resection in older women with low-risk early stage primary invasive ductal carcinoma o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive ductal carcinoma of the breast
- Tumor size ≤ 3 cm
- No extensive intraductal component
- Tumor must not be attached to the skin, underlying muscle, or chest wall
- Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist
- Tumor amenable to segmental mastectomy (i.e., lumpectomy)
- No bilateral breast cancer
- No clinical or radiographic multifocal disease not amenable to single segmental mastectomy
- Patients with \> 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 48 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- 0-2
- Life expectancy
- At least 5 years
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant
- Fertile patients must use effective contraception
- No collagen vascular disease
- No medical condition that would preclude surgery
- Other prior malignancy allowed provided the following criteria are met:
- Patient has undergone potential curative therapy for all prior malignancies
- There is no evidence of any prior malignancy within the past 5 years
- Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for this malignancy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy to the breast
- Surgery
- No breast implants
Exclusion
Key Trial Info
Start Date :
March 18 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2019
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00182728
Start Date
March 18 2003
End Date
June 13 2019
Last Update
October 1 2024
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295