Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: 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.
Procedure: synchronous resection surgery
Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery
Other Names:
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Outcome Measures
Primary Outcome Measures
- Resectable outcome [8 weeks]
R0 resection rate of liver metastases; Intra operative accident; Post-operative accident
Secondary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients from 18 to 75 years
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Able to give informed consent
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Have a histological adenocarcinoma diagnosis of colorectal cancer
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Resected or operable colorectal primary tumor
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Initially unresectable liver lesion considered by multidisciplinary team (MDT)
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World Health Organisation performance status (ECOG PS) 0, 1
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Adequate complete blood count, liver and renal function
Exclusion Criteria:
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Prior history of other active malignancies
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Unmeasurable lesion according to RECIST criteria v.1.1
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Recurrence of colorectal cancer
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Resection or ablation of liver lesion
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Distant metastases outside the liver
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Patients who have received prior chemotherapy with Oxaliplatin, Irinotecan, Capecitabine, 5-Fluoro-uracil.
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Concomitant uncontrollable medical status ie. symptomatic cardiac disease, infarction within 24 months, uncontrollable cardiac dysrhythmia, active infectious disease
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Pathology of the liver lesion except adenocarcinoma metastasis from colorectal cancer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5 | Ho Chi Minh City | Vietnam |
Sponsors and Collaborators
- Cho Ray Hospital
- University of Medicine and Pharmacy at Ho Chi Minh City
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Cho Ray hospital