Clinical trial · Interventional
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
NCT00143403CI-TRIAL-00003967completedPhase 3Results postedClinicalTrials.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)
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folinic Acid + 5 FU | Drug | — | UNRESOLVED |
| Irinotecan + 5 FU + folinic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Irinotecan + 5 FU + folinic acid
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: Folinic Acid + 5 FU
Primary outcomes (1)
- measure
- Disease Free Survival (DFS)
- timeFrame
- last tumor assessment date or cut-off date, whichever is earlier.
- description
- time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour. * Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion. * Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases. Exclusion Criteria: * Prior hepatic radiation or resection. * Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es). * Prior chemotherapy for metastatic disease.
References
Publications (0)
Data not yet available
No reference posted for this study.