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Sponsored by: |
Eastern Network of Cancer Immunological Therapy, Japan |
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Information provided by: | Eastern Network of Cancer Immunological Therapy, Japan |
ClinicalTrials.gov Identifier: | NCT00503321 |
A randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary endpoint of this study is progression-free survival (PFS), with secondary endpoints of anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors.
Condition | Intervention | Phase |
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Gastric Cancer |
Drug: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK) Drug: Tegafur/gimeracil/oteracil potassium (S-1) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma |
Enrollment: | 13 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm B: Experimental
S-1 plus PSK group
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Drug: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)
S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day
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Arm A: Active Comparator
S-1 alone
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Drug: Tegafur/gimeracil/oteracil potassium (S-1)
S-1 80mg/m2, 4weeks on followed by 2 weks off
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Tegafur / gimeracil / oteracil potassium (TS-1) is widely used as a first-line drug for unresectable advanced gastric carcinoma and recurrent gastric carcinoma in Japan and the response rate of TS-1 against gastric carcinoma was reported to be excellent at 46.5% in a phase II study. However, since adverse drug reactions tend to occur in patients treated with standard regimen of TS-1, drug reduction or discontinuation is often required, which is one drawback of this drug. On the other hand, although Krestin (PSK) has been reported to show survival effects in postoperative immunochemotherapy against gastric carcinoma, the efficacy of PSK has not been established in patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma. Since the main effect of PSK was to recover physiological functions, including immune function of the host, it was expected that PSK would improve the compliance of TS-1 by alleviating adverse drug reactions of TS-1 therapy and the concomitant use of TS-1 with PSK would result in the improvement of treatment results. Therefore, we decided to conduct a randomized phase II study on patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1+PSK therapy.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Shizuoka Cancer Center | |
Shizuoka, Japan, 411-8777 |
Study Chair: | Hideaki Tahara, MD | Eastern Network of Cancer Immunological Therapy, Japan |
Responsible Party: | Shizuoka Cancer Center ( Masanori Terashima ) |
Study ID Numbers: | ENCITJ-GC01 |
Study First Received: | July 16, 2007 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00503321 History of Changes |
Health Authority: | Japan: Institutional Review Board; Japan: Ministry of Health, Labor and Welfare |
gastric cancer, TS-1, PSK |
Antimetabolites Anti-Infective Agents Radiation-Protective Agents Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Tegafur Interferons Adjuvants, Immunologic Antiviral Agents |
Recurrence Carcinoma Anti-Bacterial Agents Digestive System Diseases Stomach Diseases Stomach Neoplasms Gastrointestinal Neoplasms Stomach Cancer PS-K Neoplasms, Glandular and Epithelial |
Antimetabolites Interferon Inducers Anti-Infective Agents Radiation-Protective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Stomach Diseases Neoplasms by Site Stomach Neoplasms |
Therapeutic Uses Digestive System Neoplasms Neoplasms by Histologic Type Tegafur Adjuvants, Immunologic Protective Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Gastrointestinal Neoplasms PS-K Neoplasms, Glandular and Epithelial |