NCT02885753

Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival. The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance. In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Oxaliplatin intravenous	85 mg/m² in intravenous. 1 cycle each 15 days
DRUG	5 FU bolus	5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous
DRUG	Folinic acid	400 mg/m² in intravenous
DRUG	Oxaliplatin intra-arteriel	85 mg/m² in intra-arterial. 1 cycle each 15 days
DRUG	Panitumumab	Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous
DRUG	Bevacizumab	5 mg/kg at each cycle in intravenous
DRUG	5 FU continuous	2400 mg/m² intravenously over 46 hours
DRUG	Irinotecan	150 mg/m² intravenous

Timeline

• Start date: 2016-12-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2016-08-31
• Last updated: 2025-07-09

Locations

49 sites across 2 countries: Belgium, France