Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
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.
Long-Term Effects Secondary to Cancer Therapy in Adults
Skin Reactions Secondary to Radiation Therapy
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Radiation: intracavitary balloon brachytherapy
Radiation: proton beam radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Accelerated Partial Breast Irradiation|
- Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy [ Designated as safety issue: Yes ]
- Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up [ Designated as safety issue: Yes ]
- Site of disease recurrence (i.e., local, regional, or distant) [ Designated as safety issue: No ]
- Time to recurrence [ Designated as safety issue: No ]
- Time to locoregional recurrence [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599989
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Lilie Lin, MD||Abramson Cancer Center of the University of Pennsylvania|