Actively Recruiting
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
Led by Federation Francophone de Cancerologie Digestive · Updated on 2025-07-09
348
Participants Needed
49
Research Sites
613 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma with liver metastases
- At least one measurable liver metastasis according to RECIST v1.1
- No other metastases except up to 3 lung nodules smaller than 10 mm
- Known RAS mutation status (KRAS and NRAS tested)
- Age 18 years or older
- WHO performance status 2 or less
- No prior chemotherapy except perioperative or adjuvant stopped over 12 months ago
- Life expectancy longer than 3 months
- Adequate blood counts: neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 9 g/dL
- Liver enzymes and bilirubin within specified limits
- Creatinine clearance over 50 mL/min
- Affiliated with a social security scheme
- Provided informed consent
You will not qualify if you...
- Contraindications to hepatic artery catheter placement such as thrombosis or problematic artery anatomy
- Eligible for immediate curative surgery or percutaneous treatment
- Recent serious heart conditions or stroke within 6 months
- Uncontrolled hypertension
- Recent abdominal fistula, gastrointestinal perforation, abscess, or active bleeding
- Ongoing gastroduodenal ulcer, wound, or fractured bone
- Recent major surgery or radiation within 4 weeks
- Transplant recipients, HIV positive or other immune deficiencies
- Progressive liver, kidney, or lung failure within 6 months
- Peripheral neuropathy greater than grade 1
- Interstitial pneumonitis or pulmonary fibrosis
- Chronic diarrhea or unresolved bowel obstruction
- Other cancers within 5 years except certain skin or cervical cancers
- Participation in another clinical trial with experimental treatment
- Allergy or contraindication to study drugs
- Known DPD enzyme deficiency
- Prolonged QT interval on ECG
- Low potassium, magnesium, or calcium levels
- Lack of effective contraception in patients of childbearing potential, pregnant or breastfeeding women
- Persons deprived of liberty or under supervision
- Unable to undergo regular medical monitoring due to geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 49 locations
1
Hôpital Erasme
Brussels, Belgium
Actively Recruiting
2
Chu Hotel Dieu
Angers, France
Actively Recruiting
3
Institut de Cancérologie de l'Ouest
Angers, France
Actively Recruiting
4
Hôpital Privé d'Antony
Antony, France
Actively Recruiting
5
CH Henri Duffaut
Avignon, France
Not Yet Recruiting
6
Institut du cancer Avignon Provence
Avignon, France
Actively Recruiting
7
Ch Cote Basque
Bayonne, France
Actively Recruiting
8
Clinique Belharra
Bayonne, France
Actively Recruiting
9
Centre Hospitalier
Beauvais, France
Not Yet Recruiting
10
Institut Bergonié
Bordeaux, France
Actively Recruiting
11
Polyclinique Bordeaux Nord
Bordeaux, France
Actively Recruiting
12
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
Actively Recruiting
13
CH Loire Vendée Océan
Challans, France
Not Yet Recruiting
14
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Actively Recruiting
15
Chu Le Bocage
Dijon, France
Not Yet Recruiting
16
Chd Vendee
La Roche-sur-Yon, France
Actively Recruiting
17
Groupe Hospitalier de la Rochelle Re-Aunis
La Rochelle, France
Actively Recruiting
18
Ch de Bicetre
Le Kremlin-Bicêtre, France
Not Yet Recruiting
19
GH Nord Essone
Longjumeau, France
Not Yet Recruiting
20
Hôpital du Scorff
Lorient, France
Actively Recruiting
21
Centre Léon Bérard
Lyon, France
Actively Recruiting
22
Hôpital de la Croix Rousse
Lyon, France
Actively Recruiting
23
Hôpital Européen
Marseille, France
Actively Recruiting
24
Hôpital Saint-Joseph
Marseille, France
Actively Recruiting
25
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
26
Chu Hotel Dieu
Nantes, France
Actively Recruiting
27
CHR La Source
Orléans, France
Not Yet Recruiting
28
Hôpital Cochin
Paris, France
Not Yet Recruiting
29
Hôpital Saint Joseph
Paris, France
Actively Recruiting
30
Hôpital Saint Louis
Paris, France
Actively Recruiting
31
Paris Hôpital Européen Georges Pompidou
Paris, France
Actively Recruiting
32
Centre Hospitalier
Pau, France
Actively Recruiting
33
Centre Hospitalier Saint Jean
Perpignan, France
Actively Recruiting
34
CHU Haut Lévêque
Pessac, France
Actively Recruiting
35
CHU La Milétrie
Poitiers, France
Actively Recruiting
36
Centre Eugène Marquis
Rennes, France
Actively Recruiting
37
Clinique Pasteur
Ris-Orangis, France
Not Yet Recruiting
38
CROME
Ris-Orangis, France
Not Yet Recruiting
39
CHU Charles Nicolle
Rouen, France
Actively Recruiting
40
CHP
Saint-Grégoire, France
Actively Recruiting
41
Institut de cancérologie de l'Ouest
Saint-Herblain, France
Actively Recruiting
42
CHU Saint-Etienne
Saint-Priest-en-Jarez, France
Actively Recruiting
43
Hôpital FOCH
Suresnes, France
Actively Recruiting
44
Maison de Santé Protestante de Bordeaux Bagatelle
Talence, France
Not Yet Recruiting
45
Hia Sainte Anne
Toulon, France
Actively Recruiting
46
Chu Toulouse Rangueil
Toulouse, France
Actively Recruiting
47
Clinique Pasteur
Toulouse, France
Not Yet Recruiting
48
Hôpital Paul Brousse
Villejuif, France
Not Yet Recruiting
49
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
S
Sofia JOURDAN
CONTACT
M
Marie MOREAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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