A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 1, 2005

Last Updated Date

May 31, 2007

Start Date ^†

November 2000

Current Primary Outcome Measures ^†

overall survival

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00142350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

time to treatment failure
incidences of adverse events
response rate
non-hospitalized survival

Original Secondary Outcome Measures ^†

time to treatment failure
incidences of adverse events
response rate
non-hospitalized survival

Descriptive Information

Brief Title ^†

A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

Official Title ^†

Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)

Brief Summary

To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer

Detailed Description

From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Gastric Cancer

Intervention ^†

Drug: continuous infusion of 5-fluorouracil
Drug: combination of irinotecan and cisplatin
Drug: oral administration of S-1

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

690

Completion Date

January 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

unresectable or recurrent histologically proved gastric cancer
adequate oral intake
age 20 or older and 75 or younger
Performance Status (ECOG):0, 1, 2
measurable or unmeasurable lesions
preserved organ functions
no severe medical condition
no prior chemotherapy for gastric cancer
written informed consent

Exclusion Criteria:

patient with marked infection or inflammation
patient with severe peritoneal metastasis
patient with massive pleural effusion
patient with metastasis to CNS
patient with diarrhea 4 or more times per day
patient severe medical condition
patient with other concurrent malignancy affecting on survival or adverse events
pregnant or nursing patient or with intent to bear baby
patient evaluated to be inadequate by a attending doctor
patient requiring nutritional support

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00142350

Responsible Party

Secondary IDs ^††

C000000062

Study Sponsor ^†

Japan Clinical Oncology Group

Collaborators ^††

Japanese Ministry of Health, Labor and Welfare
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD

Investigators ^†

Study Chair:

Atsushi Ohtsu, MD

National Cancer Centr Hospital East

Information Provided By

Japan Clinical Oncology Group

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.