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

Japan Clinical Oncology Group

Status and phase

Completed

Phase 3

Conditions

Gastric Cancer

Treatments

Drug: oral administration of S-1

Drug: continuous infusion of 5-fluorouracil

Drug: combination of irinotecan and cisplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00142350

JCOG9912

C000000062

Details and patient eligibility

About

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

Full 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).

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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