Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments s1, oxaliplatin
Phase phase 1/phase 2
Sponsor Chinese Academy of Medical Sciences
Start date June 2011
End date September 2014
Trial size 71 participants
Trial identifier NCT01542294, CH-GI-020

Summary

The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
s1+oxaliplatin
s1 TS-1
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
oxaliplatin Eloxatin
130mg/m2 d1 repeated every 21 days

Primary Outcomes

Measure
chemotherapy complete rate
time frame: 6 months

Secondary Outcomes

Measure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 3 years
recurrence-free survival(RFS)
time frame: 3 years
overall survival(OS)
time frame: 3 years

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

Inclusion Criteria: - 20-70 years - Histologically proven adenocarcinoma of the stomach - Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery - Stage II, III (AJCC 7th edition) - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - No prior chemotherapy or radiotherapy - Adequate bone marrow, renal, and liver function Exclusion Criteria: - Any evidence of metastatic disease (including presence of tumor cells in the ascites). - Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer. - Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. - Pregnant or lactating women. - History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. - Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication. - Organ allografts requiring immunosuppressive therapy. - Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. - Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications. - Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.

Additional Information

Official title Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
Principal investigator Lin Yang, MD
Description This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences.