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Sponsors and Collaborators: |
James A. Haley Veterans Administration Hospital Hoffmann-La Roche |
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Information provided by: | James A. Haley Veterans Administration Hospital |
ClinicalTrials.gov Identifier: | NCT00216424 |
This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 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.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Capecitabine (Xeloda) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma |
Estimated Enrollment: | 40 |
Study Start Date: | February 2005 |
Study Completion Date: | January 2007 |
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who fulfill any of the following criteria will be excluded:
Any of the following laboratory values:
Note: In patients with moderate renal impairment (estimated creatinine clearance 30-50 mL/min) at baseline, a dose reduction to 75% of the capecitabine starting dose is recommended.
United States, Florida | |
James A. Haley Veterans Administration Hospital | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Ismail Kazem, MD | James A. Haley Veterans Administration Hospital |
Study ID Numbers: | XEL372 |
Study First Received: | September 21, 2005 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00216424 |
Health Authority: | United States: Federal Government |
Colon cancer Rectal cancer |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Carcinoma Rectal neoplasm Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |