Clinical trial · Observational
Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer
Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases
NCT05362825CI-TRIAL-00058409unknownClinicalTrials.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 single arm study aims to evaluate the rate of conversion therapy in patients with unresectable liver-limited metastatic colorectal cancer (mCRC) using FOLFOXIRI neoadjuvant regimen and to assess the other outcome including the response rate, the survival rate and the safety profile.
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 |
|---|---|---|---|
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
| Synchronous Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neo-adjuvant Chemotherapy FOLFOXIRI Regimen | Drug | — | UNRESOLVED |
| synchronous resection surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Un-resectable synchronous liver limited metastasis colorectal cancer
- description
- Un-resectable synchronous liver limited metastasis colorectal cancer patients undergoing neo-adjuvant chemotherapy FOLFOXIRI regimen, up to 12 cycles.
- interventionNames
- Drug: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen
- Procedure: synchronous resection surgery
Primary outcomes (1)
- measure
- Resectable outcome
- timeFrame
- 8 weeks
- description
- R0 resection rate of liver metastases; Intra operative accident; Post-operative accident
Secondary outcomes (3)
- measure
- Progression free survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients from 18 to 75 years * Able to give informed consent * Have a histological adenocarcinoma diagnosis of colorectal cancer * Resected or operable colorectal primary tumor * Initially unresectable liver lesion considered by multidisciplinary team (MDT) * World Health Organisation performance status (ECOG PS) 0, 1 * Adequate complete blood count, liver and renal function Exclusion Criteria: * Prior history of other active malignancies * Unmeasurable lesion according to RECIST criteria v.1.1 * Recurrence of colorectal cancer * Resection or ablation of liver lesion * Distant metastases outside the liver * Patients who have received prior chemotherapy with Oxaliplatin, Irinotecan, Capecitabine, 5-Fluoro-uracil. * Concomitant uncontrollable medical status ie. symptomatic cardiac disease, infarction within 24 months, uncontrollable cardiac dysrhythmia, active infectious disease * Pathology of the liver lesion except adenocarcinoma metastasis from colorectal cancer.
References
Publications (5)
- RESULTSiriwardena AK, Mason JM, Mullamitha S, Hancock HC, Jegatheeswaran S. Management of colorectal cancer presenting with synchronous liver metastases. Nat Rev Clin Oncol. 2014 Aug;11(8):446-59. doi: 10.1038/nrclinonc.2014.90. Epub 2014 Jun 3. PMID 24889770
- RESULTMasi G, Allegrini G, Cupini S, Marcucci L, Cerri E, Brunetti I, Fontana E, Ricci S, Andreuccetti M, Falcone A. First-line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): results of a phase II study with a simplified biweekly schedule. Ann Oncol. 2004 Dec;15(12):1766-72. doi: 10.1093/annonc/mdh470. PMID 15550581
- RESULTSouglakos J, Androulakis N, Syrigos K, Polyzos A, Ziras N, Athanasiadis A, Kakolyris S, Tsousis S, Kouroussis Ch, Vamvakas L, Kalykaki A, Samonis G, Mavroudis D, Georgoulias V. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer. 2006 Mar 27;94(6):798-805. doi: 10.1038/sj.bjc.6603011. PMID 16508637
- RESULTMarques RP, Duarte GS, Sterrantino C, Pais HL, Quintela A, Martins AP, Costa J. Triplet (FOLFOXIRI) versus doublet (FOLFOX or FOLFIRI) backbone chemotherapy as first-line treatment of metastatic colorectal cancer: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2017 Oct;118:54-62. doi: 10.1016/j.critrevonc.2017.08.006. Epub 2017 Aug 25. PMID 28917269
- DERIVEDHao VDT, Tri PM, My DT, Anh LT, Trung LV, Bac NH, Vuong NL. FOLFOXIRI for First-Line Treatment of Unresectable Colorectal Cancer with Liver Metastases in a Resource-Limited Setting. J Gastrointest Cancer. 2024 Oct 31;56(1):12. doi: 10.1007/s12029-024-01133-4. PMID 39480530