Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients with liver-only metastases colorectal cancer could potentially be cured following surgical resection of metastases. Recent evidence suggest that a triplet chemotherapy regimen, FOLFOXIRI has been associated with higher R0 resection. Eighty-nine eligible patients will be recruited at Cho Ray hospital in Vietnam. Patients will receive neoadjuvant FOLFOXIRI regimen every two weeks for up to 12 cycles and will undergo periodic imaging studies. The resectability of liver metastases will be assessed by a multidisciplinary team comprised of digestive surgeons, hepato-biliary surgeons, radiologists, and oncologists. This study will be helpful to establish a standard chemotherapy regimen for patients with liver-limited metastatic colorectal cancer. Moreover, this study will assess the surgical outcome, the response rate, the survival rate, the safety of triple drug chemotherapy and the association between conversion operable disease and various survival rate and patient's characteristics.

Official Title
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Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases

Conditions
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Liver Metastasis Colon Cancer, Synchronous Neoplasm

Intervention / Treatment
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* Drug: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen
* Procedure: synchronous resection surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Un-resectable synchronous liver limited metastasis colorectal cancer<br>Un-resectable synchronous liver limited metastasis colorectal cancer patients undergoing neo-adjuvant chemotherapy FOLFOXIRI regimen, up to 12 cycles. | Drug: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen<br>* Oxaliplatin 85mg/m2 IV; Irrinotecan 165mg/m2 IV; Leucovorin 400mg/m2 IV; 5-Fluorouracil 2400mg/m2 continuous infusion in 46 hours - every 2-week cycle, up to 12 cycles.<br>Procedure: synchronous resection surgery<br>* Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery<br>* Other names: No surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resectable outcome | R0 resection rate of liver metastases; Intra operative accident; Post-operative accident | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 5 years | 
| Overall survival |  | 5 years | 
| The incidence of chemotherapy related adverse events | Incidence of the adverse events in any grade; the serious adverse events | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FOLFOXIRI