Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients (TMOG-GC01)
Tracking Information | |||||
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First Received Date ICMJE | May 28, 2008 | ||||
Last Updated Date | March 20, 2012 | ||||
Start Date ICMJE | June 2008 | ||||
Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Relapse-free survival [ Time Frame: Five years after surgery ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00687843 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers [ Time Frame: Five years after surgery ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients | ||||
Official Title ICMJE | Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients | ||||
Brief Summary | Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients. |
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Detailed Description | TS-1 is an oral anticancer drug approved in Japan consisting of tegafur (a pro-drug of fluorouracil, 5-FU), gimeracil and oteracil potassium. The response rate of TS-1 in the untreated advanced gastric cancer patients was 44.6% in the late phase II study. In 2007, efficacy of the adjuvant therapy using TS-1 in the resected gastric cancer patients was demonstrated by ACTS-GC study group conducted in Japan. PSK is an oral anticancer drug approved in Japan consisting of protein-bound polysaccharide extracted from mycelium of Trametes (Coriolus) versicolor, a kind of mushroom. Even though survival benefit by PSK in combination with adjuvant chemotherapy using 5-FU or tegafur in the postoperative gastric cancer patients was already demonstrated, it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer. In this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Gastric Cancer | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 480 | ||||
Estimated Completion Date | March 2016 | ||||
Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 20 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Japan | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00687843 | ||||
Other Study ID Numbers ICMJE | TMOG-GC01 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Yoshiaki Iwasaki, M.D., Ph.D., Tokyo Metropolitan Oncology Group | ||||
Study Sponsor ICMJE | Tokyo Metropolitan Oncology Group | ||||
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Investigators ICMJE |
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Information Provided By | Tokyo Metropolitan Oncology Group | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |