Status:
TERMINATED
3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-120 years
Phase:
NA
Brief Summary
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damag...
Detailed Description
OBJECTIVES: Primary * To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brach...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically proven invasive ductal carcinoma of the breast
- Stage I or II disease (pathological tumor size ≤ 3 cm, N0, M0 disease)
- No T2 (tumor size \> 3 cm) or T3 disease
- No lymph node (L0) or hemangiosis (V0) invasion
- Unilateral, unifocal, and unicentric tumor without associated suspicious diffuse microcalcification in the ipsilateral or contralateral breast
- No multifocal/multicentric disease
- Previously treated with breast-conserving surgery with adequate axillary node management
- Negative surgical resection margins for tumor (invasive tumor or ductal carcinoma in situ \[DCIS\]) on histology
- Clearly identified primary tumor excision cavity (clips recommended) with a target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the post-operative CT scan
- Patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible but will undergo partial breast irradiation using multi-catheter interstitial brachytherapy during study
- Breast size amenable to partial breast irradiation (i.e., \> A-cup size)
- No other pathological invasive tumor or DCIS
- No associated extensive DCIS component (\< 25%)
- No associated Paget's disease of the nipple
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No breast implants
- No collagen vascular disease
- No psychiatric condition or other condition that, in the opinion of the investigator, would preclude study requirements
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy
- No concurrent chemotherapy
- Sequential chemotherapy allowed
- Concurrent hormonal therapy allowed
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00802711
Start Date
October 1 2009
End Date
August 1 2011
Last Update
April 6 2023
Active Locations (1)
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1
Saint Luke's Radiation Oncology Network
Dublin, Ireland, 6