Clinical trial · Interventional
Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
NCT00639327CI-TRIAL-00005102completedPhase 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)
The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan | Drug | Irinotecan | ALIAS |
| S-1 + irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- CPT-11+ S-1
- interventionNames
- Drug: S-1 + irinotecan
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- CPT-11
- interventionNames
- Drug: irinotecan
Primary outcomes (1)
- measure
- In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet.
- timeFrame
- Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma * Subjects must be able to take orally * Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11 * Within 4 weeks from the diagnosis of PD * Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination * ECOG performance status ≤ 1 * Follow up Age 20 or over * Life expectancy estimated more than 12 weeks * Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3 * Creatinine ≤ upper normal limit (UNL) * Total bilirubin ≤ 1.5 X UNL * Written informed consent Exclusion Criteria: * S-1 + CPT-11 was employed as a first-line * Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy * After S-1 adjuvant * Suspended cases by adverse events by S-1 or S-1 combination * Excessive amounts of ascites require drainage * Known brain metastases * History of hypersensitivity to fluoropyrimidines and CPT-11 * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * Active double cancer * Gastrointestinal bleeding * Any subject judged by the investigator to be unfit for any reason to participate in the study
References
Publications (1)
- DERIVEDTanabe K, Fujii M, Nishikawa K, Kunisaki C, Tsuji A, Matsuhashi N, Takagane A, Ohno T, Kawase T, Kochi M, Yoshida K, Kakeji Y, Ichikawa W, Chin K, Terashima M, Takeuchi M, Nakajima T. Phase II/III study of second-line chemotherapy comparing irinotecan-alone with S-1 plus irinotecan in advanced gastric cancer refractory to first-line treatment with S-1 (JACCRO GC-05). Ann Oncol. 2015 Sep;26(9):1916-1922. doi: 10.1093/annonc/mdv265. Epub 2015 Jun 24. PMID 26109630