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SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01542294
Recruitment Status : Unknown
Verified June 2016 by Lin Yang, Chinese Academy of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2012
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 16, 2011
First Posted Date  ICMJE March 2, 2012
Last Update Posted Date June 14, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2016)
chemotherapy complete rate [ Time Frame: 6 months ]
percentage of patients who completed eight cycles of chemotherapy
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2012)
3 year recurrence-free survival(RFS) [ Time Frame: 3 years ]
from the date of surgery until the occurrence of an event (relapse or death whichever came first)
Change History Complete list of historical versions of study NCT01542294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2016)
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ]
    assessed from surgery until 1 months after withdrawing from study
  • recurrence-free survival(RFS) [ Time Frame: 3 years ]
    from the date of surgery until the occurrence of an event (relapse or death whichever came first)
  • overall survival(OS) [ Time Frame: 3 years ]
    from the date of surgery to any cause of death
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2012)
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ]
    assessed from surgery until 1 months after withdrawing from study
  • 3 year of overall survival [ Time Frame: 3 years ]
    from the date of surgery to any cause of death
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: treatment
s1+oxaliplatin
Interventions:
  • Drug: s1
  • Drug: Oxaliplatin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 12, 2016)
71
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2012)
70
Estimated Study Completion Date  ICMJE April 2017
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01542294
Other Study ID Numbers  ICMJE CH-GI-020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lin Yang, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lin Yang, MD Department of Medical Oncology,Cancer Hospital and Institute,CAMS
PRS Account Chinese Academy of Medical Sciences
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP