Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine together with radiation therapy works in treating patients with nonmetastatic breast cancer.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Safety And Feasibility Study Of Concurrent Capecitabine (Xeloda) And External Beam Irradiation In The Adjuvant Treatment Of High Risk Early Stage Breast Cancer.|
- Overall safety [ Designated as safety issue: Yes ]
- Cosmesis, skin toxicity and wound healing at 1 year [ Designated as safety issue: Yes ]
- Recurrence at 1 year [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
- To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer.
- To determine the effects of concurrent treatment on cosmesis and wound healing at 1 year.
- To determine the short-term (1-year) risk of recurrence of breast cancer in these patients.
OUTLINE: This is a multicenter study.
Patients undergo external-beam radiotherapy once daily, 5 days a week and concurrently receive oral capecitabine twice daily, 5 days a week Monday through Friday, for approximately 6-7 weeks.
After completion of study therapy, patients are followed at approximately 1 week, 1 month, 6 months, and 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562718
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Study Chair:||Dan P. Garwood, MD||Simmons Cancer Center|