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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-18

Study Completion Date

2025-01-23

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.

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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.

Conditions

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Liver Metastasis Colon Cancer Synchronous Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Un-resectable synchronous liver limited metastasis colorectal cancer

Un-resectable synchronous liver limited metastasis colorectal cancer patients undergoing neo-adjuvant chemotherapy FOLFOXIRI regimen, up to 12 cycles.

Neo-adjuvant Chemotherapy FOLFOXIRI Regimen

Intervention Type DRUG

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.

synchronous resection surgery

Intervention Type PROCEDURE

Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery

Interventions

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Neo-adjuvant Chemotherapy FOLFOXIRI Regimen

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.

Intervention Type DRUG

synchronous resection surgery

Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery

Intervention Type PROCEDURE

Other Intervention Names

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Liver-first surgery Primary/Bowel-first Surgery No surgery

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No