Radiation Therapy With Capecitabine in Rectal Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00176787 |
Recruitment Status
:
Terminated
(recruitment goals met)
First Posted
: September 15, 2005
Last Update Posted
: January 10, 2008
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | September 12, 2005 | |||
First Posted Date ICMJE | September 15, 2005 | |||
Last Update Posted Date | January 10, 2008 | |||
Study Start Date ICMJE | October 2000 | |||
Actual Primary Completion Date | May 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | Complete list of historical versions of study NCT00176787 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Radiation Therapy With Capecitabine in Rectal Cancer | |||
Official Title ICMJE | Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046) | |||
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 patient's 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 patient's 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 | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Rectal Cancer | |||
Intervention ICMJE |
|
|||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE |
30 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | June 2007 | |||
Actual Primary Completion Date | May 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Eligibility Criteria
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00176787 | |||
Other Study ID Numbers ICMJE | UMCC 0046 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | University of Michigan Cancer Center | |||
Collaborators ICMJE | Hoffmann-La Roche | |||
Investigators ICMJE |
|
|||
PRS Account | University of Michigan Cancer Center | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |