FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM

Sponsor
Sun Yat-sen University
Study ID
NCT03678428
Phase
PHASE3
Status
Terminated

Conditions

  • Liver Metastases
  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and 15.
  • Oxaliplatin HAI — DRUG
    Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.
  • Floxuridine — DRUG
    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.
  • Leucovorin — DRUG
    Leucovorin 200mg/m2 IV on Day 1 and 15.
  • 5-FU — DRUG
    5-FU 2400mg/m2 CIV in 46h on Day 1 and 15.
  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m2 IV over 3 hours on Day1 and 15.

Study Details

The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.

Key Dates

Start date
Dec 31, 2021
Status verified
Feb 2023
Primary completion
Oct 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FUDR/Oxaliplatin HAI plus irinotecan
    Patients will receive Systemic CPT-11 + HAI (FUDR+L-OHP) every 28 days: Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; followed by Oxaliplatin 85 mg/m2 over 3 hours through the HAI pump on Day 1 and 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. then Irinotecan 150 mg/m2 IV over 90 minutes on Day 15, followed by Oxaliplatin 85 mg/m2 IV over 3 hours on Day 15. 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.
  • Active Comparator: FOLFOXIRI
    Patients will receive Systemic FOLFOXIRI every 28 days: Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and Day 15; Oxaliplatin 85 mg/m2 IV in 3-6 hours on Day 1 and Day 15; Leucovorin 200mg/m2 and 5-FU 2400mg/m2 CIV in 46 hours on Day 1 and Day 15.

Primary Outcome Measure

Overall Response Rate and bilateral 95% confidence interval [ Time Frame: Up to 2-4 months ]

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