Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176787
Status:
TERMINATED
Last Update Posted:
2008-01-10
First Post:
2005-09-12
Brief Title:
Radiation Therapy With Capecitabine in Rectal Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer UMCC 0046
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment goals met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patients tumor The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer
This is a phase II clinical trial which means that the physician will be studying the reactions of the patients body and tumor to treatment with Capecitabine and radiation therapy The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur
Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects
This is a phase II clinical trial which means that the physician will be studying the reactions of the patients body and tumor to treatment with Capecitabine and radiation therapy The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur
Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects
Detailed Description:
None
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