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RECRUITING
NCT02885753
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

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

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