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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: | NCT00209729 |
To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: Taxotere Drug: TS-1 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | March 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Docetaxel plus S-1
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Drug: Taxotere
X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
Drug: TS-1
Day 1-14, P.O. everyday
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A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly patients with histological stage IV gastric cancer given Docetaxel 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: | 76 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yoshito Komatsu, MD, PhD | +81-11-716-1161 | ykomatsu@med.hokudai.ac.jp |
Contact: Satoshi Yuki, MD | +81-11-716-1161 | satoshi-yuuki175@joy.ocn.ne.jp |
Japan, Hokkaido | |
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine) | Recruiting |
Sapporo, Hokkaido, Japan, 060-8638 | |
Contact: Yoshito Komatsu, MD, PhD +81-11-716-1161 ykomatsu@med.hokudai.ac.jp | |
Contact: Satoshi Yuki, MD +81-11-716-1161 satoshi-yuuki175@joy.ocn.ne.jp |
Study Chair: | Masahiro Asaka, MD, PhD | Hokkaido Gastrointestinal Cancer Study Group |
Study ID Numbers: | HGCSG0502, DS-Elderly |
Study First Received: | September 13, 2005 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00209729 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Docetaxel S-1 Elderly Patients Gastric cancer |
Docetaxel Stomach Diseases Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |