Liver Metastasis Colon Cancer, Synchronous Neoplasm
Conditions
Keywords
FOLFOXIRI
Brief summary
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
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.
Interventions
DRUGNeo-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.
PROCEDUREsynchronous resection surgery
Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Cho Ray Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resectable outcome | 8 weeks | R0 resection rate of liver metastases; Intra operative accident; Post-operative accident |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 5 years | — |
| Overall survival | 5 years | — |
| The incidence of chemotherapy related adverse events | 2 weeks | Incidence of the adverse events in any grade; the serious adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between R0 procedure and patient's characteristics. | 8 weeks | age, sex, ECOG PS, colon site, Carcinoembryonic antigen (CEA) level, RAS/ BRAF gene mutation, chemotherapy cycle numbers, Early tumor shrinkage; Depth of response; Surgery procedure; Liver lesion's number; Liver lesion's site, Liver lesion's dimension |
| Correlation between R0 procedure and survival time | 5 years | Progression free survival (PFS) time, Overall survival (OS) time |
Countries
Vietnam
Contacts
Primary ContactHao Dinh Thy Vuong, MD
Outcome results
None listed