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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- progression-free survival — 24 months after randomization
comparison of radiological/clinical progression free survival
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Erasme | Brussels | Belgium | Recruiting |
| Chu Hotel Dieu | Angers | France | Recruiting |
| Institut de Cancérologie de l'Ouest | Angers | France | Recruiting |
| Hôpital Privé d'Antony | Antony | France | Recruiting |
| CH Henri Duffaut | Avignon | France | Not Yet Recruiting |
| Institut du cancer Avignon Provence | Avignon | France | Recruiting |
| Ch Cote Basque | Bayonne | France | Recruiting |
| Clinique Belharra | Bayonne | France | Recruiting |
| Centre Hospitalier | Beauvais | France | Not Yet Recruiting |
| Institut Bergonié | Bordeaux | France | Recruiting |
| Polyclinique Bordeaux Nord | Bordeaux | France | Recruiting |
| Infirmerie Protestante de Lyon | Caluire-et-Cuire | France | Recruiting |
| CH Loire Vendée Océan | Challans | France | Not Yet Recruiting |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | Recruiting |
| Chu Le Bocage | Dijon | France | Not Yet Recruiting |
| Chd Vendee | La Roche-sur-Yon | France | Recruiting |
| Groupe Hospitalier de la Rochelle Re-Aunis | La Rochelle | France | Recruiting |
| Ch de Bicetre | Le Kremlin-Bicêtre | France | Not Yet Recruiting |
| GH Nord Essone | Longjumeau | France | Not Yet Recruiting |
| Hôpital du Scorff | Lorient | France | Recruiting |
| Centre Léon Bérard | Lyon | France | Recruiting |
| Hôpital de la Croix Rousse | Lyon | France | Recruiting |
| Hôpital Européen | Marseille | France | Recruiting |
| Hôpital Saint-Joseph | Marseille | France | Recruiting |
| Institut Paoli Calmettes | Marseille | France | Not Yet Recruiting |
| Chu Hotel Dieu | Nantes | France | Recruiting |
| CHR La Source | Orléans | France | Not Yet Recruiting |
| Hôpital Cochin | Paris | France | Not Yet Recruiting |
| Hôpital Saint Joseph | Paris | France | Recruiting |
| Hôpital Saint Louis | Paris | France | Recruiting |
| Paris Hôpital Européen Georges Pompidou | Paris | France | Recruiting |
| Centre Hospitalier | Pau | France | Recruiting |
| Centre Hospitalier Saint Jean | Perpignan | France | Recruiting |
| CHU Haut Lévêque | Pessac | France | Recruiting |
| CHU La Milétrie | Poitiers | France | Recruiting |
| Centre Eugène Marquis | Rennes | France | Recruiting |
| Clinique Pasteur | Ris-Orangis | France | Not Yet Recruiting |
| CROME | Ris-Orangis | France | Not Yet Recruiting |
| CHU Charles Nicolle | Rouen | France | Recruiting |
| CHP | Saint-Grégoire | France | Recruiting |
+ 9 more sites — see the full list on the official registry below.
On this site
📄 Avastin (bevacizumab) drug profile →More Federation Francophone de Cancerologie Digestive trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02885753 on ClinicalTrials.gov ↗ ← All trials in France