Clinical trial · Interventional
Intensified Chemotherapy in CRC After Resection of Liver Metastases
Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.
NCT00208260CI-TRIAL-00102463completedPhase 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)
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFIRI-HD | Drug | — | UNRESOLVED |
| FOLFIRINOX | Drug | — | UNRESOLVED |
| FOLFOX-4 | Drug | FOLFOX Regimen | ALIAS |
| FOLFOX-7 | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- FOLFIRI
- interventionNames
- Drug: FOLFIRI
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- FOLFOX-4
- interventionNames
- Drug: FOLFOX-4
- type
- EXPERIMENTAL
- label
- C
- description
- FOLFIRI-HD
- interventionNames
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 without previous resection, or clinically asymptomatic (with or without stent) * Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver. * Not optimally resectable metastases * Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable. * Synchronous and metachronous hepatic metastases * WHO performance status 0-1 * Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination. * No prior treatment of the liver metastases, whatever. * Life expectancy equal or more than 3 months Exclusion Criteria: \-
References
Publications (1)
- RESULTYchou M, Rivoire M, Thezenas S, Quenet F, Delpero JR, Rebischung C, Letoublon C, Guimbaud R, Francois E, Ducreux M, Desseigne F, Fabre JM, Assenat E. A randomized phase II trial of three intensified chemotherapy regimens in first-line treatment of colorectal cancer patients with initially unresectable or not optimally resectable liver metastases. The METHEP trial. Ann Surg Oncol. 2013 Dec;20(13):4289-97. doi: 10.1245/s10434-013-3217-x. Epub 2013 Aug 17. PMID 23955585