Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to "Low-risk" Breast Cancer Patients
Phase 4
Completed
- Conditions
- Breast Cancer
- Interventions
- Device: Accelerated partial breast irradiation
- Registration Number
- NCT00882596
- Lead Sponsor
- Cancer Center of Irvine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
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 T2. 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)
- T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage of T3 or T4
- Estrogen receptor negative tumor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Accelerated partial breast irradiation Contura accelerated partial breast irradiation. Following a lumpectomy, a Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial breast irradiation begins.
- Primary Outcome Measures
Name Time Method Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose. 19 months
- Secondary Outcome Measures
Name Time Method Toxicity rates 79 months
Trial Locations
- Locations (1)
Cancer Center of Irvine
🇺🇸Irvine, California, United States