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Sponsored by: |
Hokkaido Gastrointestinal Cancer Study Group |
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Information provided by: | Hokkaido Gastrointestinal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00209638 |
To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase I/II study of this combination in patients with inoperable or with postoperative gastric cancer
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: irinotecan Drug: S-1 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0101 |
Estimated Enrollment: | 24 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | April 2003 |
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for gastric 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:
・ Eligibility criteria
Exclusion Criteria:
Study ID Numbers: | HGCSG0002 |
Study First Received: | September 13, 2005 |
Last Updated: | April 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00209638 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Irinotecan, S-1, Phase I/II, gastric cancer |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Irinotecan Gastrointestinal Neoplasms Stomach cancer |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |