SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

Phase 1

• Conditions: Gastric Cancer
• Interventions: Drug: s1; Drug: Oxaliplatin

• Registration Number: NCT01542294
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-10-16
• Study First Submitted QC: 2012-02-25
• Study First Posted: 2012-03-02
• Primary Completion: 2014-09
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-12
• Last Update Posted: 2016-06-14
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	s1	s1+oxaliplatin
treatment	Oxaliplatin	s1+oxaliplatin

Primary Outcome Measures

Name	Time	Method
chemotherapy complete rate	6 months	percentage of patients who completed eight cycles of chemotherapy

Secondary Outcome Measures

Name	Time	Method
overall survival(OS)	3 years	from the date of surgery to any cause of death
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 years	assessed from surgery until 1 months after withdrawing from study
recurrence-free survival(RFS)	3 years	from the date of surgery until the occurrence of an event (relapse or death whichever came first)

Trial Locations

Locations (1)

Department of Medical Oncology,Cancer hospital and Institute,CAMS; 🇨🇳 Beijing, China