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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00869570 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving radiation therapy together with capecitabine and sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with sorafenib and external-beam radiation therapy and to see how well it works in treating patients with locally advanced rectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: capecitabine Drug: sorafenib tosylate Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Neoadjuvant Radiotherapy Combined With Capecitabine and Sorafenib in Patients With Advanced, K-Ras Mutated Rectal Cancer. A Multicenter Phase I/IIa Trial. |
Estimated Enrollment: | 47 |
Study Start Date: | March 2009 |
OBJECTIVES:
OUTLINE: This is a multicenter, phase I, dose-escalation study of capecitabine followed by a phase II study.
Patients receive oral capecitabine twice daily and oral sorafenib tosylate twice daily on days 1-33. Patients also undergo external-beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Approximately 6 weeks after completion of neoadjuvant therapy, patients undergo surgery.
After completion of study therapy, patients are followed at 8 weeks and then periodically for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced adenocarcinoma of the rectum (with or without nodal involvement) requiring surgery
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Switzerland | |
Kantonsspital Graubuenden | Recruiting |
Chur, Switzerland, CH-7000 | |
Contact: Roger von Moos, MD 41-81-256-6644 roger.vonmoos@ksgr.ch |
Principal Investigator: | Roger von Moos, MD | Kantonsspital Graubuenden |
Study ID Numbers: | CDR0000634955, SWS-SAKK-41/08, EudraCT-2008-006312-38, EU-20809 |
Study First Received: | March 25, 2009 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00869570 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the rectum stage II rectal cancer stage III rectal cancer |
Antimetabolites Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Intestinal Diseases Protein Kinase Inhibitors |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Adenocarcinoma Sorafenib Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Enzyme Inhibitors Intestinal Diseases |
Protein Kinase Inhibitors Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Sorafenib Colorectal Neoplasms |