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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Gastric Cancer

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: continuous infusion of 5-fluorouracil|nan|
|Drug: combination of irinotecan and cisplatin|nan|
|Drug: oral administration of S-1|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to treatment failure |  |  | 
| incidences of adverse events |  |  | 
| response rate |  |  | 
| non-hospitalized survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, 5-fluorouracil, irinotecan, cisplatin, S-1, advanced or recurrent gastric cancer