Adjuvant Systemic Chemotherapy With or Without HAI-FUDR in Patients With Resected CRLM

Sponsor
Sun Yat-sen University
Study ID
NCT03500874
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FUDR — DRUG
    Floxuridine(FUDR) 0.12 mg/kg/day，on Day 1-14 through the HAI pump.
  • Oxaliplatin — DRUG
    Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.
  • Leucovorin — DRUG
    Leucovorin 200mg/m2 ivd over 2 hours on Day 1
  • 5FU — DRUG
    5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
  • Irinotecan — DRUG
    Irinotecan 180mg/m2

Study Details

HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Key Dates

Start date
May 28, 2018
Status verified
Jan 2024
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021

Study Design

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

Arms

  • Experimental: HAI group
    Patients will receive systemic chemotherapy on days 1 and 15 using either of the following regimens: mFOLFOX6 (Oxaliplatin 85 mg/m2; Leucovorin 200mg/m2; followed by an infusion of 5-fluorouracil 2.4 g/m2 administered over 46 hours) or mFOLFIRI (Irinotecan 180mg/m2; Leucovorin 200mg/m2; followed by an infusion of 5-fluorouracil 2.4 g/m2 administered over 46 hours) For HAI, FUDR was administered as a continuous infusion of 0.12 mg/kg/day over 14 days via the HAI pump, along with dexamethasone 20 mg, and normal saline was used to fill up the 300ml pump reservoir.
  • Active Comparator: Non-HAI group
    Patients will receive systemic chemotherapy on days 1 and 15 using either of the following regimens: mFOLFOX6 (oxalipatin 85 mg/m2 infusion for 3 h, Leucovorin 200 mg/m2 for 3 h and 5-FU 2,400 mg/m2 continuous infusion for 46 h) or mFOLFIRI (Irinotecan 180mg/m2; Leucovorin 200mg/m2; 5-FU 2,400 mg/m2 continuous infusion for 46 h).

Primary Outcome Measure

3 Year Relapse Free Survival Rate [ Time Frame: up to 36 months ]

Related Studies