Clinical Trial of Chemosensitivity Test

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: S-1

• Registration Number: NCT00287755
• Lead Sponsor: Japan Clinical Cancer Research Organization

Brief Summary

To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-07
• Study Start: 2006-03
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• histologically proven gastric cancer
• PS (ECOG) 0 or 2
• D2 dissection, curability B or more
• surgical Stage IIIA and IIIB
• negative peritoneal cytology
• no previous radiotherapy, chemotherapy and hormone therapy
• possible peroral intake at 6 POW
• no severe surgical complication
• normal bone marrow, liver and renal function
• complete chemosensitivity test
• written informed consent

Exclusion Criteria

• multiple cancer
• contraindication for S-1
• history of drug allergy (grade 3)
• severe complication
• watery diarrhea
• pregnant
• scirrhous gastric cancer
• the other patients who was judged as inadequate for trial by doctor on duty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	S-1	-

Primary Outcome Measures

Name	Time	Method
Overall survival rate	at three years

Secondary Outcome Measures

Name	Time	Method
Side effect	During administration of drug

Trial Locations

Locations (36)

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Gunma University Hospital; 🇯🇵 Maehashi, Gunma, Japan

Hakodate Goryoukaku Hopsital; 🇯🇵 Hakodate, Hokkaido, Japan

Hyogo Prefectural Awaji Hospital; 🇯🇵 Sumoto, Hyogo, Japan

Ishikawa Prefectural Central Hospital; 🇯🇵 Kanazawa, Ishikawa, Japan

Kanazawa Medical University Hospital; 🇯🇵 Kanazawa, Ishikawa, Japan

Iwate Medical University Hospital; 🇯🇵 Morioka, Iwate, Japan

Nippon Medical School Second Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan

St. Marianna University, School of Medicine; 🇯🇵 Kawasaki, Kanagawa, Japan

Kitazato University East Hospital; 🇯🇵 Sagamihara, Kanagawa, Japan

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