Status:
UNKNOWN
Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer
Lead Sponsor:
Cho Ray Hospital
Collaborating Sponsors:
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions:
Liver Metastasis Colon Cancer
Synchronous Neoplasm
Eligibility:
All Genders
18-75 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 23 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05362825
Start Date
February 18 2022
End Date
January 23 2025
Last Update
May 11 2022
Active Locations (1)
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1
Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5
Ho Chi Minh City, Vietnam