Clinical trial · Interventional
Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer
Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer
NCT00506571CI-TRIAL-00000802TIROX2unknownPhase 2ClinicalTrials.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)
Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorecal Neoplasms | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Secondary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1, irinotecan, oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximal overall response rate
- timeFrame
- During chemotherapy
Secondary outcomes (1)
- measure
- Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent * At least one unidimensional measurable lesion * ECOG performance status 0-2. * No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment * Adequate major organ functions * Give written informed consent Exclusion Criteria: * Prior systemic chemotherapy for metastatic disease * Prior treatment with oxaliplatin or irinotecan * Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration * Prior surgical treatment of stage IV disease is permitted * CNS metastases * Prior history of peripheral neuropathy ≥ NCI CTC grade 1 * Uncontrolled or severe cardiovascular disease * Serious concurrent infection or nonmalignant illness * Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix * Organ allografts requiring immunosuppressive therapy * Psychiatric disorder or uncontrolled seizure that would preclude compliance * Pregnant, nursing women or patients with reproductive potential without contraception * Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al. * Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency * Known hypersensitivity to platinum compounds or any of the components of the study medications * Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery * Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
References
Publications (0)
Data not yet available
No reference posted for this study.