Clinical trial · Interventional
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)
NCT00142350CI-TRIAL-00023833completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combination of irinotecan and cisplatin | Drug | — | UNRESOLVED |
| continuous infusion of 5-fluorouracil | Drug | — | UNRESOLVED |
| oral administration of S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- overall survival
Secondary outcomes (4)
- measure
- time to treatment failure
- measure
- incidences of adverse events
- measure
- response rate
- measure
- non-hospitalized survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDKurokawa Y, Boku N, Yamaguchi T, Ohtsu A, Mizusawa J, Nakamura K, Fukuda H. Inter-institutional heterogeneity in outcomes of chemotherapy for metastatic gastric cancer: correlative study in the JCOG9912 phase III trial. ESMO Open. 2016 Feb 8;1(1):e000031. doi: 10.1136/esmoopen-2015-000031. eCollection 2016. PMID 27843586
- DERIVEDTakahari D, Boku N, Mizusawa J, Takashima A, Yamada Y, Yoshino T, Yamazaki K, Koizumi W, Fukase K, Yamaguchi K, Goto M, Nishina T, Tamura T, Tsuji A, Ohtsu A. Determination of prognostic factors in Japanese patients with advanced gastric cancer using the data from a randomized controlled trial, Japan clinical oncology group 9912. Oncologist. 2014 Apr;19(4):358-66. doi: 10.1634/theoncologist.2013-0306. Epub 2014 Mar 25. PMID 24668328
- DERIVEDBoku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Takiuchi H, Nasu J, Ohtsu A; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol. 2009 Nov;10(11):1063-9. doi: 10.1016/S1470-2045(09)70259-1. Epub 2009 Oct 7. PMID 19818685