NCT00882596
Completed
Phase 4
A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity
ConditionsBreast Cancer
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Cancer Center of Irvine
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.
Detailed Description
The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able and willing to sign informed consent
- •Age 50 or older at diagnosis
- •Life expectancy greater than 10 years (excluding diagnosis of breast cancer)
- •Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria)
- •On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma
- •For patients with invasive breast cancer, an axillary staging procedure must be performed \[either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative\]
- •The T stage must be Tis, T1, or T
- •If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter
- •Estrogen receptor positive tumor
Exclusion Criteria
- •Age \< 50 at diagnosis (regardless of histology)
- •Pregnant or breast-feeding
- •Active collagen vascular disease
- •Paget's disease of the breast
- •Prior history of DCIS or invasive breast cancer
- •Prior breast or thoracic radiation therapy for any condition
- •Multicentric carcinoma (DCIS or invasive)
- •Synchronous bilateral invasive or non-invasive breast cancer
- •Surgical margins that cannot be microscopically assessed or that are positive
- •Positive axillary node(s)
Outcomes
Primary Outcomes
Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
Time Frame: 19 months
Secondary Outcomes
- Toxicity rates(79 months)
Study Sites (1)
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