A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus O... | NCT01946061

Studies
A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer

NCT01946061

Sponsor

Yonsei University

Status

Terminated

Last Update Posted

Aug 19, 2016Estimated

Enrollment

3Actual

Phase

Phase 2

Conditions

Advanced Gastric Cancer

Interventions

S-1 plus oxaliplatin

Countries

South Korea

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was stopped because of difficulties of supplying the drug.

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Sep 12, 2013

First Submission Date that Met QC Criteria

Sep 16, 2013

First Posted Date

Sep 19, 2013Estimated

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

Aug 18, 2016

Last Update Posted Date

Aug 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental		Drug: S-1 plus oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-1 plus oxaliplatin	Drug	Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year disease-free survival	3-year disease-free survival will be assessed by imaging study including CT and PET.	3 years from the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age, between 19 and 75
Histologically proven advanced gastric cancer
R0 resection after D2 gastrectomy
Stage III (according to the AJCC 7th criteria)
ECOG status 0 to 2

Exclusion Criteria:

Malignancy history other than gastric cancer
Previous chemotherapy history for gastric cancer
Previous radiotherapy history for gastric cancer
Pregnancy or breast milk feeding
Grade 3 or more of neuropathy
Active infection
Severe hepatic dysfunction
Severe renal dysfunction
Severe bone marrow dysfunction
Significant neurologic or psychologic disease
Inadequate condition for receiving chemotherapy due to significant systemic disease
Patients who receives drugs which can be interacted with S-1

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Severnace Hospital		Seoul		120-752	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17978289	Background	Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.

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

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Term
C079198	S 1 (combination)
D000077150	Oxaliplatin