SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer | NCT01542294

Studies
SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

NCT01542294

Sponsor

Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Jun 14, 2016Estimated

Enrollment

71Actual

Phase

Phase 1Phase 2

Conditions

Gastric Cancer

Interventions

s1
Oxaliplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Sep 2014Actual

Completion Date

Apr 2017Estimated

First Submitted Date

Oct 16, 2011

First Submission Date that Met QC Criteria

Feb 25, 2012

First Posted Date

Mar 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2016

Last Update Posted Date

Jun 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Label	Type	Description	Intervention Names
treatment	Experimental	s1+oxaliplatin	Drug: s1 Drug: Oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
s1	Drug	60-90mg/m2/d P.O. day 1-14, repeated every 21 days	treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
chemotherapy complete rate	percentage of patients who completed eight cycles of chemotherapy	6 months

Secondary Outcomes

Measure	Description	Time Frame
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
recurrence-free survival(RFS)	from the date of surgery until the occurrence of an event (relapse or death whichever came first)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lin Yang, MD	Department of Medical Oncology,Cancer Hospital and Institute,CAMS	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Oncology,Cancer hospital and Institute,CAMS		Beijing		100021	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29743043	Derived	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.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
C079198	S 1 (combination)
C103828	titanium silicide
D000077150	Oxaliplatin

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals