Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery
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|ClinicalTrials.gov Identifier: NCT00562718|
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 22, 2007
Last Update Posted : September 25, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: capecitabine Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2004|
|Estimated Primary Completion Date :||September 2009|
- Overall safety
- Cosmesis, skin toxicity and wound healing at 1 year
- Recurrence at 1 year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|