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Sponsors and Collaborators: |
University of Michigan Cancer Center Hoffmann-La Roche |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00176787 |
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.
Condition | Intervention | Phase |
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Rectal Cancer |
Drug: Capecitabine Procedure: Radiation Procedure: Surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046) |
Estimated Enrollment: | 30 |
Study Start Date: | October 2000 |
Study Completion Date: | June 2007 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Criteria
Exclusion Criteria:
United States, Michigan | |
University of Michigan Cancer Center | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Mark Zalupski, M.D. | University of Michigan Cancer Center |
Study ID Numbers: | UMCC 0046 |
Study First Received: | September 12, 2005 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00176787 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Rectal Neoplasm Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Rectal Neoplasms Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |