Clinical trial · Interventional
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
NCT02688023CI-TRIAL-00021039unknownPhase 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)
Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
- description
- Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
- interventionNames
- Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
Primary outcomes (1)
- measure
- 3-year disease-free survival
- timeFrame
- 5 years
Secondary outcomes (5)
- measure
- objective response rate
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * histologically verified colorectal cancer * clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only) * age: 18-70 years * ECOG 0-2 * adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease) * no prior cancer and/or chemotherapy * signed informed consent Exclusion Criteria: * patients with a history of prior malignancy * pregnant or lactating patients * known or suspected brain metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.