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SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
s1
Oxaliplatin
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, S-1, oxaliplatin, adjuvant chemotherapy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Medical Oncology,Cancer hospital and Institute,CAMS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

s1+oxaliplatin

Outcomes

Primary Outcome Measures

chemotherapy complete rate
percentage of patients who completed eight cycles of chemotherapy

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2011
Last Updated
June 12, 2016
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01542294
Brief Title
SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, S-1, oxaliplatin, adjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
s1+oxaliplatin
Intervention Type
Drug
Intervention Name(s)
s1
Other Intervention Name(s)
TS-1
Intervention Description
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
130mg/m2 d1 repeated every 21 days
Primary Outcome Measure Information:
Title
chemotherapy complete rate
Description
percentage of patients who completed eight cycles of chemotherapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
assessed from surgery until 1 months after withdrawing from study
Time Frame
3 years
Title
recurrence-free survival(RFS)
Description
from the date of surgery until the occurrence of an event (relapse or death whichever came first)
Time Frame
3 years
Title
overall survival(OS)
Description
from the date of surgery to any cause of death
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Yang, MD
Organizational Affiliation
Department of Medical Oncology,Cancer Hospital and Institute,CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology,Cancer hospital and Institute,CAMS
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29743043
Citation
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.
Results Reference
derived

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SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

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