SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01542294
First received: October 16, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: s1
Drug: Oxaliplatin
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 3 year recurrence-free survival(RFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    from the date of surgery until the occurrence of an event (relapse or death whichever came first)


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    assessed from surgery until 1 months after withdrawing from study

  • 3 year of overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    from the date of surgery to any cause of death


Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
s1+oxaliplatin
Drug: s1
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
Other Name: TS-1
Drug: Oxaliplatin
130mg/m2 d1 repeated every 21 days
Other Name: Eloxatin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542294

Contacts
Contact: Wen Zhang, MD 86-10-87788145 wenwen0605@163.com

Locations
China
Department of Medical Oncology,Cancer hospital and Institute,CAMS Recruiting
Beijing, China, 100021
Contact: Wen Zhang, MD    86-10-87788145    wenwen0605@163.com   
Principal Investigator: Lin Yang, MD         
Principal Investigator: Jinwan Wang, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Lin Yang, MD Department of Medical Oncology,Cancer Hospital and Institute,CAMS
  More Information

No publications provided

Responsible Party: Lin Yang, associated professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01542294     History of Changes
Other Study ID Numbers: CH-GI-020
Study First Received: October 16, 2011
Last Updated: November 26, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
gastric cancer
S-1
oxaliplatin
adjuvant chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014