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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
Sponsor: Federation Francophone de Cancerologie Digestive
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
348
Start Date
2016-12
Completion Date
2028-09
Last Updated
2025-07-09
Healthy Volunteers
No
Conditions
Interventions
Oxaliplatin intravenous
85 mg/m² in intravenous. 1 cycle each 15 days
5 FU bolus
5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous
Folinic acid
400 mg/m² in intravenous
Oxaliplatin intra-arteriel
85 mg/m² in intra-arterial. 1 cycle each 15 days
Panitumumab
Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous
Bevacizumab
5 mg/kg at each cycle in intravenous
5 FU continuous
2400 mg/m² intravenously over 46 hours
Irinotecan
150 mg/m² intravenous
Locations (49)
Hôpital Erasme
Brussels, Belgium
Chu Hotel Dieu
Angers, France
Institut de Cancérologie de l'Ouest
Angers, France
Hôpital Privé d'Antony
Antony, France
CH Henri Duffaut
Avignon, France
Institut du cancer Avignon Provence
Avignon, France
Ch Cote Basque
Bayonne, France
Clinique Belharra
Bayonne, France
Centre Hospitalier
Beauvais, France
Institut Bergonié
Bordeaux, France
Polyclinique Bordeaux Nord
Bordeaux, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
CH Loire Vendée Océan
Challans, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Chu Le Bocage
Dijon, France
Chd Vendee
La Roche-sur-Yon, France
Groupe Hospitalier de la Rochelle Re-Aunis
La Rochelle, France
Ch de Bicetre
Le Kremlin-Bicêtre, France
GH Nord Essone
Longjumeau, France
Hôpital du Scorff
Lorient, France
Centre Léon Bérard
Lyon, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Européen
Marseille, France
Hôpital Saint-Joseph
Marseille, France
Institut Paoli Calmettes
Marseille, France
Chu Hotel Dieu
Nantes, France
CHR La Source
Orléans, France
Hôpital Cochin
Paris, France
Hôpital Saint Joseph
Paris, France
Hôpital Saint Louis
Paris, France
Paris Hôpital Européen Georges Pompidou
Paris, France
Centre Hospitalier
Pau, France
Centre Hospitalier Saint Jean
Perpignan, France
CHU Haut Lévêque
Pessac, France
CHU La Milétrie
Poitiers, France
Centre Eugène Marquis
Rennes, France
Clinique Pasteur
Ris-Orangis, France
CROME
Ris-Orangis, France
CHU Charles Nicolle
Rouen, France
CHP
Saint-Grégoire, France
Institut de cancérologie de l'Ouest
Saint-Herblain, France
CHU Saint-Etienne
Saint-Priest-en-Jarez, France
Hôpital FOCH
Suresnes, France
Maison de Santé Protestante de Bordeaux Bagatelle
Talence, France
Hia Sainte Anne
Toulon, France
Chu Toulouse Rangueil
Toulouse, France
Clinique Pasteur
Toulouse, France
Hôpital Paul Brousse
Villejuif, France
Institut Gustave Roussy
Villejuif, France