Clinical trial · Interventional
Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients
Phase II Study of 2-weekly Raltitrexed Plus Irinotecan Regimen (RAILIRI) Versus Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) as Second-line Treatment in Advanced Colorectal Cancer Patients
NCT02376452CI-TRIAL-00016971unknownPhase 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)
This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.
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 Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RALIRI
- description
- Raltitrexed combined with irinotecan
- interventionNames
- Drug: Raltitrexed
- Drug: Irinotecan
- type
- PLACEBO_COMPARATOR
- label
- FOLFIRI
- description
- 5-fluorouracil,folinate combined with irinotecan
- interventionNames
- Drug: Irinotecan
- Drug: 5-fluorouracil
- Drug: Leucovorin
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma * Eastern Cooperative Oncology Group performance status of 0 to 1 * life expectancy of ≥ 3 months * patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin) * at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria * have adequate bone marrow, hepatic, and renal function Exclusion Criteria: * patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction * patients with symptomatic brain metastases * active clinical severe infection * previously received irinotecan or raltitrexed * dihydropyrimidine dehydrogenase (DPD) enzyme adequate
References
Publications (0)
Data not yet available
No reference posted for this study.