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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00142350

Enrollment

690

Registered

2005-09-02

Start date

2000-11-30

Completion date

2007-01-31

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

gastric cancer, 5-fluorouracil, irinotecan, cisplatin, S-1, advanced or recurrent gastric cancer

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).

Interventions

DRUGcontinuous infusion of 5-fluorouracil

DRUGcombination of irinotecan and cisplatin

DRUGoral administration of S-1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. unresectable or recurrent histologically proved gastric cancer 2. adequate oral intake 3. age 20 or older and 75 or younger 4. Performance Status (ECOG):0, 1, 2 5. measurable or unmeasurable lesions 6. preserved organ functions 7. no severe medical condition 8. no prior chemotherapy for gastric cancer 9. written informed consent

Exclusion criteria

1. patient with marked infection or inflammation 2. patient with severe peritoneal metastasis 3. patient with massive pleural effusion 4. patient with metastasis to CNS 5. patient with diarrhea 4 or more times per day 6. patient severe medical condition 7. patient with other concurrent malignancy affecting on survival or adverse events 8. pregnant or nursing patient or with intent to bear baby 9. patient evaluated to be inadequate by a attending doctor 10. patient requiring nutritional support

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
time to treatment failure	—
incidences of adverse events	—
response rate	—
non-hospitalized survival	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026