Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216424
Status:
TERMINATED
Last Update Posted:
2007-11-12
First Post:
2005-09-21
Brief Title:
Capecitabine Xeloda and Radiation for Patients With Rectosigmoid Carcinoma
Sponsor:
James A Haley Veterans Administration Hospital
Organization:
James A Haley Veterans Administration Hospital
Study Overview
Official Title:
An Open Label Phase II Study of Capecitabine Xeloda Plus Conformal Radiotherapy for Patients With Locally Advanced Non-Metastatic Rectosigmoid Carcinoma
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed primarily to establish efficacy and estimate resource utilization The short-term hypothesis is that the dose of capecitabine 825 mgm2 twiceday 5 days per week during the course of radiation therapy is efficacious in locally advanced non-metastatic rectosigmoid carcinoma and will improve resectability The long-term working hypothesis is that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity In addition it is expected that the simplicity of using an oral agent capecitabine will be associated with reduced cost and resource utilization
Detailed Description:
Patients will all receive the combined treatment of 3-D external radiation therapy plus Xeloda External Radiation Therapy to the pelvis lower abdomen and rectal area will be given once a day five days a week Monday through Friday for about five to six weeks using three dimensional techniques
Xeloda oral chemotherapy is a pill taken by mouth This medication will be taken during the course of radiation therapy on days that radiation treatments are given Xeloda pills will be taken twice daily beginning with the first day of radiation therapy treatments and ending on the last day of radiation therapy treatment
The following tests and procedures are part of regular medical treatment standard care for the disease and are also required for this study
physical examinations sometimes including a digital rectal exam
blood tests including a blood pregnancy test will be done before starting treatment if the patient is a woman able to have children
urinalysis
ECG heart tracing
chest X-ray
ultrasound which produces pictures of the rectal area using sound waves CT scan of the pelvis and abdomen
Some people may need surgery others may require more chemotherapy and others may require no additional treatment depending on how their tumor responded to the Xeloda and radiation therapy treatments
Patients will also be asked to complete two questionnaires about their fatigue general quality of life and bowel functioning
Xeloda oral chemotherapy is a pill taken by mouth This medication will be taken during the course of radiation therapy on days that radiation treatments are given Xeloda pills will be taken twice daily beginning with the first day of radiation therapy treatments and ending on the last day of radiation therapy treatment
The following tests and procedures are part of regular medical treatment standard care for the disease and are also required for this study
physical examinations sometimes including a digital rectal exam
blood tests including a blood pregnancy test will be done before starting treatment if the patient is a woman able to have children
urinalysis
ECG heart tracing
chest X-ray
ultrasound which produces pictures of the rectal area using sound waves CT scan of the pelvis and abdomen
Some people may need surgery others may require more chemotherapy and others may require no additional treatment depending on how their tumor responded to the Xeloda and radiation therapy treatments
Patients will also be asked to complete two questionnaires about their fatigue general quality of life and bowel functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None