NCT03678428

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Previous studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. Hepatic arterial infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion oxaliplatin and FUDR could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to compare objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases.

Conditions

• Metastatic Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and 15.
DRUG	Oxaliplatin HAI	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.
DRUG	Floxuridine	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.
DRUG	Leucovorin	Leucovorin 200mg/m2 IV on Day 1 and 15.
DRUG	5-FU	5-FU 2400mg/m2 CIV in 46h on Day 1 and 15.
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m2 IV over 3 hours on Day1 and 15.

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2018-09-19
• Last updated: 2023-02-16

Locations

1 site across 1 country: China