Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Cur... | NCT01283217

Studies
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer

NCT01283217

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jun 4, 2013Estimated

Enrollment

166Estimated

Phase

Phase 3

Conditions

Gastric Adenocarcinoma

Interventions

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

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Jan 24, 2011

First Posted Date

Jan 25, 2011Estimated

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 1, 2013

Last Update Posted Date

Jun 4, 2013Estimated

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

Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46~56% and a median survival time of 14.0~14.3 months.

Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DS(Docetaxel with S-1)	Experimental	Docetaxel with S-1	Drug: DS
SP(S-1 with cisplatin)	Active Comparator	S-1 with cisplatin	Drug: SP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DS	Drug	Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.	DS(Docetaxel with S-1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year disease free survival(DFS)	Tumor assessments with chest X-rays and CT or MRI scan will be done at 6 months after randomization (after the end of the treatment period), then every 3 months for the first 2 years after randomization and then every 6 months for coming 3 years then one year basis until completion of the study.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
ECOG performance status 0-1
Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
D2 lymph node dissection with R0 surgery
Signed informed consent

Exclusion Criteria:

Subjects with documented distant metastasis.
Malabsorption syndrome or disease significantly affecting gastrointestinal function
Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN
History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible.
Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
C079198	S 1 (combination)
D000077143	Docetaxel
D002945	Cisplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

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Browse Branches

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