Radiation Therapy in Treating Women With Invasive Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer.
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Radiation: radiation therapy
Early Phase 1
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Relationship Between Plasma Transforming Growth Factor-beta 1 (TGF-β) and Fractionation in Radiotherapy for Breast Cancer: A Randomized Study|
|Study Start Date:||April 2004|
|Study Completion Date:||May 2004|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
- Compare the ratio between post- and pre-treatment plasma transforming growth factor-beta 1 (TGF-β) in women with invasive breast cancer undergoing hypofractionated radiotherapy vs standard-fractionated external-beam radiotherapy.
- Establish longitudinal serum and plasma biorepository for retrospective evaluation of TGF-β and other biomarkers with special relevance to radiation response.
- Correlate pre-treatment plasma TGF-β levels with clinical fibrosis development.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (hypofractionated radiotherapy): Patients undergo external-beam radiotherapy once daily 5 days a week for up to 3.5 weeks (16 fractions total).
- Arm II (standard fractionated radiotherapy): Patients undergo radiotherapy as in arm I at a lower dose for up to 5 weeks (25 fractions total).
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301041
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Catherine C. Park, MD||University of California, San Francisco|