Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT00562718
Status:
COMPLETED
Last Update Posted:
2020-08-21
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
Primary
* To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer.
Secondary
* 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.
Primary
* To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer.
Secondary
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: