Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
|ClinicalTrials.gov Identifier: NCT00599989|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 24, 2008
Last Update Posted : July 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|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: brachytherapy Radiation: intracavitary balloon brachytherapy Radiation: proton beam radiation therapy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Masking:||None (Open Label)|
|Official Title:||Accelerated Partial Breast Irradiation|
|Study Start Date :||January 2005|
|Estimated Primary Completion Date :||January 2010|
- Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
- Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up
- Site of disease recurrence (i.e., local, regional, or distant)
- Time to recurrence
- Time to locoregional recurrence
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|