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 Hospital

Status: Enrolling

Conditions: Synchronous Neoplasm; Liver Metastasis Colon Cancer

Treatments: Drug: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen; Procedure: synchronous resection surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05362825

Cho Ray hospital

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 89 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

89 participants in 1 patient group

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.

Treatment:

Procedure: synchronous resection surgery

Drug: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen