Trials / Completed
CompletedNCT00599989
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
Accelerated Partial Breast Irradiation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- Female
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Cancer
- Long-term Effects Secondary to Cancer Therapy in Adults
- Skin Reactions Secondary to Radiation Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | adjuvant therapy | |
| PROCEDURE | conventional surgery | |
| RADIATION | 3-dimensional conformal radiation therapy | |
| RADIATION | brachytherapy | |
| RADIATION | intracavitary balloon brachytherapy | |
| RADIATION | proton beam radiation therapy |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2009-05-11
- Completion
- 2009-05-11
- First posted
- 2008-01-24
- Last updated
- 2020-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT00599989. Inclusion in this directory is not an endorsement.