SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01542294
• Other study ID #: CH-GI-020
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 16, 2011
• Last updated: June 12, 2016
• Start date: June 2011
• Est. completion date: April 2017

Study information

• Verified date: June 2016
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: April 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• s1
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
• Oxaliplatin
130mg/m2 d1 repeated every 21 days

Locations

Country	Name	City	State
China	Department of Medical Oncology,Cancer hospital and Institute,CAMS	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemotherapy complete rate	percentage of patients who completed eight cycles of chemotherapy	6 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	assessed from surgery until 1 months after withdrawing from study	3 years	Yes
Secondary	recurrence-free survival(RFS)	from the date of surgery until the occurrence of an event (relapse or death whichever came first)	3 years	No
Secondary	overall survival(OS)	from the date of surgery to any cause of death	3 years	No