Accelerated Partial Breast Irradiation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.
Detailed Description
OBJECTIVES: * To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial. * To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy. * To summarize the institutional experience of these patients treated with this experimental therapy. OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions). After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
Time Frame: 11 months
Secondary Outcomes
- Time to locoregional recurrence(11 months)
- Time to recurrence(11 months)
- Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up(11 months)
- Site of disease recurrence (i.e., local, regional, or distant)(11 months)