Clinical trial · Interventional
Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer
NCT00284258CI-TRIAL-00008406completedPhase 2 / Phase 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)
This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression free survival of IRIS in comparison with FOLFIRI.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPT-11, 5-FU and l-LV | Drug | — | UNRESOLVED |
| CPT-11 and TS-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- CPT-11 and TS-1
- interventionNames
- Drug: CPT-11 and TS-1
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- CPT-11, 5-FU and l-LV
- interventionNames
- Drug: CPT-11, 5-FU and l-LV
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- every course for first three courses, then every other course
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal cancer * Locally advanced and/or metastatic colorectal cancer * Have prior chemotherapy as first line treatment * No prior irinotecan administration * Able to take oral medication * Age 20 to 75 * Performance status 0 or 1 (ECOG) * WBC 3,000-12,000 / mm\^3 * Platelet ≥100,000 / mm\^3 * AST and ALT ≤ 100 IU/L * Creatinine ≤ 1.2 mg/dL * Bilirubin ≤ 1.5 mg/dL Exclusion Criteria: * Prior radio therapy for colorectal cancer * Other malignancies in the past 5 years * Serious illness or medical condition
References
Publications (2)
- RESULTMuro K, Boku N, Shimada Y, Tsuji A, Sameshima S, Baba H, Satoh T, Denda T, Ina K, Nishina T, Yamaguchi K, Takiuchi H, Esaki T, Tokunaga S, Kuwano H, Komatsu Y, Watanabe M, Hyodo I, Morita S, Sugihara K. Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 non-inferiority study (FIRIS study). Lancet Oncol. 2010 Sep;11(9):853-60. doi: 10.1016/S1470-2045(10)70181-9. Epub 2010 Aug 12. PMID 20708966
- DERIVEDYasui H, Muro K, Shimada Y, Tsuji A, Sameshima S, Baba H, Satoh T, Denda T, Ina K, Nishina T, Yamaguchi K, Esaki T, Tokunaga S, Kuwano H, Boku N, Komatsu Y, Watanabe M, Hyodo I, Morita S, Sugihara K. A phase 3 non-inferiority study of 5-FU/l-leucovorin/irinotecan (FOLFIRI) versus irinotecan/S-1 (IRIS) as second-line chemotherapy for metastatic colorectal cancer: updated results of the FIRIS study. J Cancer Res Clin Oncol. 2015 Jan;141(1):153-60. doi: 10.1007/s00432-014-1783-3. Epub 2014 Aug 9. PMID 25106731