SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

NCT ID: NCT01542294

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-04-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

s1+oxaliplatin

Group Type: EXPERIMENTAL

s1

Intervention Type: DRUG

60-90mg/m2/d P.O. day 1-14, repeated every 21 days

Oxaliplatin

Intervention Type: DRUG

130mg/m2 d1 repeated every 21 days

Interventions

s1

60-90mg/m2/d P.O. day 1-14, repeated every 21 days

Intervention Type: DRUG

Oxaliplatin

130mg/m2 d1 repeated every 21 days

Intervention Type: DRUG

Other Intervention Names

TS-1; Eloxatin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Lin Yang

associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology,Cancer Hospital and Institute,CAMS

Locations

Department of Medical Oncology,Cancer hospital and Institute,CAMS

Beijing, , China

Countries

China

References

Wang G, Zhao J, Song Y, Zhang W, Sun Y, Zhou A, Huang J, Du F, Yang L. Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer. BMC Cancer. 2018 May 9;18(1):547. doi: 10.1186/s12885-018-4480-9.

Reference Type: DERIVED

PMID: 29743043 (View on PubMed)

Other Identifiers

CH-GI-020

Identifier Type: -

Identifier Source: org_study_id