Actively Recruiting

Phase 3
Age: 18Years +
All Genders
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

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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