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Sponsors and Collaborators: |
Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital |
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Information provided by: | Hokkaido Gastrointestinal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00209651 |
To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Campto, Topotesin Drug: TS-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302 |
Enrollment: | 40 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
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1: Experimental
Irinotecan and S-1
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Drug: Campto, Topotesin
q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
Drug: TS-1
80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.
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A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Hokkaido | |
Hokkaido University Hospital | |
Sapporo, Hokkaido, Japan, 060-8638 |
Study Chair: | Yoshito Komatsu, MD.PhD | Hokkaido Gastrointestinal Cancer Study Group |
Study ID Numbers: | HGCSG0302, IRIS |
Study First Received: | September 13, 2005 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00209651 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Irinotecan, S-1, Phase II, colorectal cancer, |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |