Study of S-1 Plus LV for Untreated Metastatic Colorectal... | NCT00891332

Studies
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

NCT00891332

Sponsor

Taiho Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jan 18, 2012Estimated

Enrollment

73Actual

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

S-1 plus LV (The combination therapy of S-1 and Leucovorin)

Countries

China
Japan

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jul 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Apr 30, 2009

First Submission Date that Met QC Criteria

Apr 30, 2009

First Posted Date

May 1, 2009Estimated

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

Jan 16, 2012

Last Update Posted Date

Jan 18, 2012Estimated

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

This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.

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

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	S-1 plus LV	Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-1 plus LV (The combination therapy of S-1 and Leucovorin)	Drug	S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)		During chemotherapy

Secondary Outcomes

Measure	Description	Time Frame
Safety		During chemotherapy
Progression free survival (PFS)		Until progression
Disease control rate(DCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proved adenocarcinoma
Unresectable and recurrent colorectal cancer
Age20 ≤ at enrollment
Performance status 0 or 1 (ECOG)
No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
Adequate hematologic, hepatic and renal functions
At least one measurable lesion by RECIST criteria

Exclusion Criteria:

Serious drug hypersensitivity
Pregnant or nursing
Bleeding from gastrointestinal tract
Diarrhea
Simultaneously active double cancer
Serious illness or medical condition
Brain metastasis

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

Name	Affiliation	Role
Hideo Baba, M.D.	Graduate School of Medical Sciences Kumamoto University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center, Division of Oncology		Dong Feng Dong road,Guangzhou	Guangdong	510060	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C079198	S 1 (combination)
D002955	Leucovorin

Ancestor Terms

ID	Term
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins

Browse Leaves

Not provided

Browse Branches

Not provided