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| Sponsors and Collaborators: |
Japan Clinical Cancer Research Organization Clinical Trial Coordinating Center of the Kitasato Institute |
|---|---|
| Information provided by: | Japan Clinical Cancer Research Organization |
| ClinicalTrials.gov Identifier: | NCT00287755 |
Purpose
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: S-1 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Single Blind (Investigator), Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery |
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: S-1
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
|
Patients: clinical Stage III gastric cancer patients. Informed consent will be obtained before surgery. Eligible patients: surgical Stage II, IIIA and IIIB gastric cancer patients. Chemosensitivity test: The surgical specimen will be sent Mitsubishi BCL, Co. Ltd. to be tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and dihydropyrimidine dehydrogenase mRNA. The test results will be blinded for the doctors on duty.
Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. The treatment will be continued until the recurrence or 1 year after operation. Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs.
Hypothesis: The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable survival outcome comparing with resistant cases.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tetsurou Kubota, MD, Ph.D. | 81-3-3353-1211 | tkubota@sc.itc.keio.ac.jp |
| Contact: Toshifusa Nakajima, MD, Ph.D. | 81-3-3520-0111 | nakajima@jfcr.or.jp |
Show 36 Study Locations| Principal Investigator: | Tetsuro Kubota, Processor | Keio University Hospital |
More Information
| Responsible Party: | Center of Comprehensive and Advanced Medicine, Keio University ( Tetsurou Kubota / Professor ) |
| Study ID Numbers: | JACCRO GC-04, GC-04 |
| Study First Received: | February 3, 2006 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00287755 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
gastric cancer S-1 chemosensitivity adjuvant |
|
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Adjuvants, Immunologic Gastrointestinal Neoplasms Stomach Cancer |
|
Neoplasms Stomach Diseases Digestive System Diseases Neoplasms by Site |
Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms |
