Systemic Chemotherapy With or Without Hepatic Arterial Infusion With Floxuridine in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective, Randomised, Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The primary objective of this study is to determine whether systemic chemotherapy combined with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Age: 18-70 years old

• Histologically confirmed colorectal adenocarcinoma

• Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis

• Initially unresectable colorectal liver metastasis confirmed by the multidisciplinary team (MDT)

• With no prior treatment for liver metastasis, including chemotherapy, operation, radiotherapy, transcatheter hepatic arterial chemoembolization (TACE) and targeted therapy

• Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning

• With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN

• Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L

• Grade A level of Child-Push Liver Function

• Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance \>50ml/min (Cockcroft-Gault Equation)

• ECOG performance status of 0-2

• Life expectancy ≥ 3 months

• Not appropriate for anti-EGFR or any other targeted therapy (with KRAS mutation or could not afford it)

• Patients have provided a signed Informed Consent Form

• With good compliance

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yu-hong Li, MD, Ph D
liyh@sysucc.org.cn
Time Frame
Start Date: 2014-03
Estimated Completion Date: 2024-12
Participants
Target number of participants: 142
Treatments
Experimental: Systemic chemotherapy
Patients will receive mFOLFOX6 every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15.
Experimental: Systemic chemotherapy combined with HAI
Patients will receive mFOLFOX6+HAI every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15. 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.~This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.
Related Therapeutic Areas
Sponsors
Leads: Yuhong Li

This content was sourced from clinicaltrials.gov