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

Cho Ray Hospital89 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Metastasis Colon Cancer Synchronous Neoplasm

Interventions

Neo-adjuvant Chemotherapy FOLFOXIRI RegimenDRUG

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 surgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5

Ho Chi Minh City, Vietnam

RECRUITING

Outcomes

Primary Outcomes

Resectable outcome

R0 resection rate of liver metastases; Intra operative accident; Post-operative accident

Time frame: 8 weeks

Secondary Outcomes

Progression free survival

Time frame: 5 years

Overall survival

Time frame: 5 years

The incidence of chemotherapy related adverse events

Incidence of the adverse events in any grade; the serious adverse events

Time frame: 2 weeks

Central Contacts

Hao Dinh Thy Vuong, MD

CONTACT

+84913122867 drthyhao@gmail.com

Data from ClinicalTrials.gov

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