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 (OSCAR)

August 16, 2023 updated by: Federation Francophone de Cancerologie Digestive

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

348

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Abbeville CEDEX, France, 80142
      • Aix-en-Provence, France, 13616
        • Recruiting
        • Centre Hospitalier du Pays d'Aix
        • Contact:
      • Amiens, France, 80054
        • Recruiting
        • Hopital Sud
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean Marc REGIMBEAU
        • Sub-Investigator:
          • Jean-Paul JOLY
        • Sub-Investigator:
          • Abdennaceur DHAHRI
        • Sub-Investigator:
          • Bruno CHAUFFERT
      • Angers, France
        • Recruiting
        • CHU - Hôtel Dieu
        • Sub-Investigator:
          • François-Xavier CAROLI-BOSC
        • Sub-Investigator:
          • Dominique LUET
        • Sub-Investigator:
          • Nathalie BAIZE
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoine HAMY
      • Antony, France, 92166
      • Auxerre, France, 89000
      • Avignon, France
        • Recruiting
        • PRIVE - Sainte Catherine
        • Sub-Investigator:
          • Rania BOUSTANY-GRENIER
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laurent Mineur
        • Sub-Investigator:
          • Benoît CALDERON
        • Sub-Investigator:
          • Philippe DEBOURDEAU
        • Sub-Investigator:
          • Philippe HUC
        • Sub-Investigator:
          • Sylvie KIRSCHER
        • Sub-Investigator:
          • Frédéric PLAT
        • Sub-Investigator:
          • Magali RAVOIRE
        • Sub-Investigator:
          • Nathalie ROUARD
        • Sub-Investigator:
          • Clémence TOULLEC
      • Bayonne CEDEX, France, 64109
        • Recruiting
        • CH - Côte Basque
        • Principal Investigator:
          • Franck AUDEMAR
        • Sub-Investigator:
          • Tam KHUONG HUU
        • Sub-Investigator:
          • Anne GUILNGAR
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Laura ETCHECHOURY
        • Sub-Investigator:
          • Anne CADIER LAGNES
        • Sub-Investigator:
          • Benoît OUI
      • Beauvais, France, 60021
      • Besançon, France, 25030
      • Beuvry, France, 62660
      • Bordeaux, France
        • Recruiting
        • PRIVE - Polyclinique Bordeaux Nord
        • Principal Investigator:
          • Cédric LECAILLE
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hervé BLANCHERE
        • Sub-Investigator:
          • Iris DEVAURE
        • Sub-Investigator:
          • Laure DUPONT KAZMA
        • Sub-Investigator:
          • Xavier MONCOUCY
      • Bordeaux CEDEX, France, 33076
      • Boulogne-sur-Mer, France, 62321
      • Boulogne-sur-Mer, France, 62222
      • Caen, France, 14076
      • Caluire-et-Cuire, France, 69300
      • Chalon-sur-Saône, France, 71100
      • Chalon-sur-Saône, France, 71100
      • Chambéry CEDEX, France, 73011
      • Chartres, France, 28018
      • Colmar, France, 68024
      • Compiègne CEDEX, France, 60204
      • Corbeil-Essonnes, France
      • Créteil CEDEX, France, 94000
      • Dijon, France, 21000
        • Recruiting
        • Institut de Cancérologie de Bourgogne - GRReCC
        • Contact:
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges-François Leclerc
        • Contact:
      • Dijon, France
        • Recruiting
        • CHU - Hôpital François Mitterand
        • Contact:
          • Sylvain MANFREDI
        • Sub-Investigator:
          • Jean-Louis JOUVE
        • Sub-Investigator:
          • Alice GAGNAIRE
        • Sub-Investigator:
          • Romaric LOFFROY
      • Grenoble CEDEX 1, France, 38028
      • Jossigny, France, 77600
      • La Roche Sur Yon, France
        • Recruiting
        • Ch - Chd Vendée
        • Contact:
        • Contact:
        • Principal Investigator:
          • Margot LALY
        • Sub-Investigator:
          • Alix LOT
        • Sub-Investigator:
          • Morgane AMIL
        • Sub-Investigator:
          • Lucile BAUGUION
        • Sub-Investigator:
          • Thierry CHARLOIS
        • Sub-Investigator:
          • Astrid DE MAISSIN
        • Sub-Investigator:
          • Frédéric DOUANE
        • Sub-Investigator:
          • Cécile GARCEAU
        • Sub-Investigator:
          • Paul GIROT
        • Sub-Investigator:
          • Véronique GIRRE
        • Sub-Investigator:
          • Carelle KOUDOUGOU
        • Sub-Investigator:
          • Ludovic LAGIN
        • Sub-Investigator:
          • Vincent MACE
        • Sub-Investigator:
          • Elodie MENAGER-TABOUREL
        • Sub-Investigator:
          • Christophe PERRET
        • Sub-Investigator:
          • Frank PRIOU
        • Sub-Investigator:
          • Jean-François RAMEE
        • Sub-Investigator:
          • Matthieu SCHNEE
      • La Tronche, France, 38700
      • Le Chesnay, France, 78157
      • Le Havre, France, 76600
      • Le Kremlin-Bicêtre, France, 94270
      • Le Mans CEDEX 9, France, 72037
      • Levallois-Perret, France, 92300
      • Longjumeau, France
        • Recruiting
        • Contact:
          • Samy LOUAFI
      • Lyon, France, 69437
      • Lyon, France
        • Recruiting
        • CAC - Léon Bernard
        • Sub-Investigator:
          • Christelle DE LA FOUCHARDIERE
        • Sub-Investigator:
          • Françoise DESSEIGNE
        • Sub-Investigator:
          • Pierre GUIBERT
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthieu SARABI
        • Sub-Investigator:
          • Charles MASTIER
      • Marseille, France
        • Recruiting
        • CH - Saint Joseph
        • Principal Investigator:
          • Herve Perrier
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Christelle BASTHISTE-PELE
        • Sub-Investigator:
          • Patrick BEAURAIN
        • Sub-Investigator:
          • Hélène BRUNETEAU
        • Sub-Investigator:
          • Olivier MONNET
        • Sub-Investigator:
          • Cyrille MULLER
      • Marseille, France
        • Recruiting
        • PRIVE - Hôpital Européen
        • Principal Investigator:
          • Yves RINALDI
        • Sub-Investigator:
          • Nicolas BARRIERE
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Frédéric COHEN
        • Sub-Investigator:
          • Cécilia SERVAJEAN
      • Marseille CEDEX 5, France, 13385
      • Meaux, France, 77100
      • Metz, France, 57000
      • Montceau-les-Mines, France, 71300
      • Montélimar, France, 26216
      • Nantes, France
        • Recruiting
        • Centre d'Imagerie médicale du Confluent- IRIS GRIM
        • Contact:
          • Jean-Marie PASQUIER
      • Nantes, France
        • Recruiting
        • CHU - Hôtel Dieu
        • Principal Investigator:
          • Yann Touchefeu
        • Sub-Investigator:
          • Frédéric DOUANE
        • Sub-Investigator:
          • Christophe PERRET
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Tamara MATYSIAK BUDNIK
        • Sub-Investigator:
          • Estelle CAUCHIN
      • Nantes, France
        • Recruiting
        • Hôpial Privé du Confluent Le Confluent Centre Catherine de Sienne
        • Contact:
          • Hélène CASTANIE
      • Orleans, France
        • Recruiting
        • CHR
        • Contact:
          • Jean-Paul LAGASSE
      • Paris, France, 75571
      • Paris, France
        • Recruiting
        • Hôpital COCHIN
        • Contact:
          • Romain CORIAT
      • Paris, France, 75248
      • Paris, France
        • Recruiting
        • CHU - Hôpital Européen George Pompidou
        • Principal Investigator:
          • Julien TAIEB
        • Sub-Investigator:
          • Céline LEPERE
        • Sub-Investigator:
          • Anne-Laure POINTET
        • Sub-Investigator:
          • Géraldine PERKINS
        • Sub-Investigator:
          • Aziz ZAANAN
        • Sub-Investigator:
          • Jean-Nicolas VAILLANT
        • Sub-Investigator:
          • Clélia COUTZAC
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Nathalie SIAUVE
        • Sub-Investigator:
          • Olivier PELLERIN
        • Sub-Investigator:
          • Jeanne NETTER-COTI
        • Sub-Investigator:
          • Simon PERNOT
      • Paris, France
        • Recruiting
        • CHU - Saint Louis
        • Principal Investigator:
          • Thomas Aparicio
        • Contact:
        • Sub-Investigator:
          • Jean-Marc GORNET
        • Contact:
        • Sub-Investigator:
          • Eric DE KERVILER
        • Sub-Investigator:
          • Nelson LOURENCO
      • Paris, France
        • Recruiting
        • PRIVE - Saint Joseph
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nabil BABA-HAMED
        • Sub-Investigator:
          • Michel GATINEAU
        • Sub-Investigator:
          • Sandra GRANIER
        • Sub-Investigator:
          • Laetitia GUILLOT
        • Sub-Investigator:
          • Eric RAYMOND
        • Sub-Investigator:
          • Francesco SAVINELLI
        • Sub-Investigator:
          • Stéphane SILVERA
        • Sub-Investigator:
          • Lionel STAUDACHER
        • Sub-Investigator:
          • Inès TORJEMAN
      • Pau, France, 64046
      • Pau, France
        • Recruiting
        • CH - Pau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mireille Simon
        • Sub-Investigator:
          • Isabelle LOURY LARIVIERE
        • Sub-Investigator:
          • Ramuntcho AROTCARENA
      • Perpignan, France
        • Recruiting
        • CH
        • Contact:
        • Principal Investigator:
          • Faiza KHEMISSA AKOUZ
        • Contact:
        • Sub-Investigator:
          • Aymeric GUIBAL
      • Pessac, France
        • Recruiting
        • CHU - Haut Lévêque
        • Principal Investigator:
          • Denis Smith
        • Contact:
        • Sub-Investigator:
          • Eric TERREBONNE
        • Contact:
        • Sub-Investigator:
          • Bruno LAPUYADE
        • Sub-Investigator:
          • Jean-Frédéric BLANC
      • Pierre-Bénite CEDEX, France, 69495
      • Poitiers, France
        • Recruiting
        • CHU
        • Principal Investigator:
          • David Tougeron
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Stéphane VELASCO
        • Sub-Investigator:
          • Violaine RANDRIAN
        • Sub-Investigator:
          • Armelle PILLET
        • Sub-Investigator:
          • Aurélie FERRU
        • Sub-Investigator:
          • Karine MOUMOUH
        • Sub-Investigator:
          • Paul Arthur HAINEAUX
        • Sub-Investigator:
          • Rayan ELFADEL
        • Sub-Investigator:
          • Anaïs DE SINGLY
        • Sub-Investigator:
          • Claire BOYER
      • Pontoise, France, 95300
      • Pringy, France, 74374
      • Périgueux, France, 24004
      • Quimper, France, 29000
      • Reims CEDEX, France, 51092
      • Rennes, France
        • Recruiting
        • CAC - Eugène Marquis
        • Sub-Investigator:
          • Julien EDELINE
        • Sub-Investigator:
          • Bérengère LECONTE
        • Sub-Investigator:
          • Astrid LIEVRE
        • Contact:
        • Contact:
        • Principal Investigator:
          • Samuel LE SOURD
        • Sub-Investigator:
          • Yann ROLLAND
        • Sub-Investigator:
          • Tanguy ROHOU
        • Sub-Investigator:
          • Marc PRACHT
        • Sub-Investigator:
          • Laurence CROUZET
        • Sub-Investigator:
          • Anaïs BODERE
      • Rennes CEDEX 9, France, 35033
      • Romans-sur-Isère, France, 26100
      • Rouen CEDEX 01, France, 76031
      • Saint Nazaire, France, 44600
        • Recruiting
        • Clinique Mutualiste de l'Estuaire - Cité Sanitaire
        • Contact:
      • Saint-Grégoire, France
        • Recruiting
        • PRIVE - Saint Grégoire
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laurent MIGLIANICO
        • Sub-Investigator:
          • Anne MERCIER BLAS
        • Sub-Investigator:
          • Romuald LE SCODAN
        • Sub-Investigator:
          • Charlotte JUHEL
        • Sub-Investigator:
          • Jérôme CHAMOIS
        • Sub-Investigator:
          • Xavier ARTIGNAN
      • Saint-Herblain, France
        • Recruiting
        • CAC - ICO Site René Gauducheau
        • Sub-Investigator:
          • Jean-Luc RAOUL
        • Contact:
        • Contact:
        • Principal Investigator:
          • Véronique GUERIN-MEYER
        • Sub-Investigator:
          • Sandrine HIRET
        • Sub-Investigator:
          • Catherine LABBE-DEVILLIERS
        • Sub-Investigator:
          • Judith RAIMBOURG
        • Sub-Investigator:
          • Hélène SENELLART
      • Saint-Malo, France, 35403
      • Saint-Priest-en-Jarez, France, 42270
      • Saint-Priest-en-Jarez, France
        • Recruiting
        • Chu - Hopital Nord Chu Saint Etienne
        • Principal Investigator:
          • Jean-Marc Phelip
        • Sub-Investigator:
          • Léa CLAVEL
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Muriel CUILLERON
      • Sainte Colombe, France, 69560
      • Senlis CEDEX, France, 60309
      • Soissons CEDEX, France, 02209
      • Strasbourg, France, 67065
      • Thonon-les-Bains, France, 74203
      • Toulon, France, 83000
      • Toulouse, France
        • Recruiting
        • CHU - Rangueil
        • Principal Investigator:
          • Rosine Guimbaud
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pascale RIVERA
        • Sub-Investigator:
          • Philippe OTAL
        • Sub-Investigator:
          • Nadim FARES
        • Sub-Investigator:
          • Marion DESLANDRES CRUCHANT
        • Sub-Investigator:
          • Corinne COUTEAU
        • Sub-Investigator:
          • Laurent BALARDY
      • Vandœuvre-lès-Nancy, France, 54519
      • Vandœuvre-lès-Nancy, France, 54511
      • Villejuif, France
        • Recruiting
        • CAC - Gustave Roussy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michel Ducreux
        • Sub-Investigator:
          • Antoine HOLLEBECQUE
        • Sub-Investigator:
          • Caroline PRIEUX-KLOTZ
        • Sub-Investigator:
          • Margarida MATIAS
        • Sub-Investigator:
          • David MALKA
        • Sub-Investigator:
          • Florence LE ROY
        • Sub-Investigator:
          • Caroline CARAMELLA
        • Sub-Investigator:
          • Pascal BURTIN
        • Sub-Investigator:
          • Valérie BOIGE
      • Villejuif, France
        • Recruiting
        • Hopital Paul Brousse
        • Contact:
          • Mohamed BOUCHAHDA
  • Switzerland
      • Baden, Switzerland
        • Recruiting
        • CH - Kantonsspital Baden
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stefanie PEDERIVA
        • Sub-Investigator:
          • Antonio NOCITO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
  • At least one measurable hepatic metastasis according to the criteria RECIST v1.1
  • No other metastatic sites except lung nodules if number ≤ 3 and < 10 mm
  • RAS mutation status known (determination of KRAS mutation (exons 2,3 and 4) and determination of the NRAS mutation (exons 2,3 and 4))
  • Age ≥ 18
  • WHO ≤ 2 (Appendix 4)
  • No prior treatment by chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
  • Life expectancy > 3 months
  • PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dLq
  • Bilirubin < 25 mmol/L, AST < 5x ULN, ALT < 5 x ULN, ALP < 5 x ULN, TP > 60%, proteinuria from 24H < 1 g
  • Creatinine clearance > 50 mL/min according to MDRD formula (Appendix 4)
  • Patient affiliated to a social security scheme
  • Patient information and signature of the informed consent

Exclusion Criteria:

  • Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
  • Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
  • Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack
  • Hypertension not controlled by medical treatment (SBP > 140 mmHg and/or DBP> 90 mmHg with blood pressure taken according to the diagram of the HAS)
  • A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
  • Progressive gastroduodenal ulcer, wound or fractured bone
  • Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment
  • Transplant patients, HIV positive or other immune deficiency syndromes
  • Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
  • Peripheral neuropathy > 1
  • Patient with interstitial pneumonitis or pulmonary fibrosis
  • History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
  • History of malignant pathologies during the past 5 years except basocellular skin carcinoma considered in complete remission or in situ cervical carcinoma, properly treated
  • Patient already included in another clinical trial with an experimental molecule
  • Any known specific contraindication or allergy or hypersensitivity to the drugs used in the study (cf RCP Appendix 7)
  • Known deficit in DPD
  • QT/QTc range > 450 msec for men and > 470 msec for women
  • K+ < LNL, Mg2+ < LNL, Ca2+ < LNL
  • Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test
  • Persons deprived of liberty or under supervision
  • Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status
Panitumumab (6 mg/kg if RAS wild) or Bevacizumab (5 mg/Kg if RAS mutated) Oxaliplatin (85 mg/m²) intraarterially Folinic Acid (400 mg/m²) intravenously 5Fu: 400 mg/m² in bolus of 10 minutes 5Fu: 2400 mg/m² intravenously over 46 hours
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
Other Names:
  • 5 FU
Drug: Folinic acid
400 mg/m² in intravenous
Other Names:
  • Folinic Acid IV
Drug: Oxaliplatin intra-arteriel
85 mg/m² in intra-arterial. 1 cycle each 15 days
Other Names:
  • Oxaliplatin IA
Drug: Panitumumab
Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous
Other Names:
  • Pani
Drug: Bevacizumab
5 mg/kg at each cycle in intravenous
Other Names:
  • Beva
Drug: 5 FU continuous
2400 mg/m² intravenously over 46 hours
Other Names:
  • 5 FU
Active Comparator: Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status
Panitumumab (6 mg/kg if RAS wild) or Bevacizumab (5 mg/Kg if RAS mutated) Oxaliplatin (85 mg/m²) intravenously Folinic Acid (400 mg/m²) intravenously 5Fu: 400 mg/m² in bolus of 10 minutes 5Fu: 2400 mg/m² intravenously over 46 hours
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
Other Names:
  • 5 FU
Drug: Folinic acid
400 mg/m² in intravenous
Other Names:
  • Folinic Acid IV
Drug: Panitumumab
Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous
Other Names:
  • Pani
Drug: Bevacizumab
5 mg/kg at each cycle in intravenous
Other Names:
  • Beva
Drug: 5 FU continuous
2400 mg/m² intravenously over 46 hours
Other Names:
  • 5 FU
Drug: Oxaliplatin intravenous
85 mg/m² in intravenous. 1 cycle each 15 days
Other Names:
  • Oxaliplatin IV
Experimental: Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab
Bevacizumab (5 mg/Kg) Oxaliplatin (85 mg/m²) intraarterially Irinotecan (150 mg/m²) intravenously Folinic Acid (400 mg/m²) intravenously 5Fu: 2400 mg/m² intravenously over 46 hours
Drug: Folinic acid
400 mg/m² in intravenous
Other Names:
  • Folinic Acid IV
Drug: Oxaliplatin intra-arteriel
85 mg/m² in intra-arterial. 1 cycle each 15 days
Other Names:
  • Oxaliplatin IA
Drug: Bevacizumab
5 mg/kg at each cycle in intravenous
Other Names:
  • Beva
Drug: 5 FU continuous
2400 mg/m² intravenously over 46 hours
Other Names:
  • 5 FU
Drug: Irinotecan
150 mg/m² intravenous
Other Names:
  • IRI
Active Comparator: Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab
Bevacizumab (5 mg/Kg) Oxaliplatin (85 mg/m²) intravenously Irinotecan (150 mg/m²) intravenously Folinic Acid (400 mg/m²) intravenously 5Fu: 2400 mg/m² intravenously over 46 hours
Drug: Folinic acid
400 mg/m² in intravenous
Other Names:
  • Folinic Acid IV
Drug: Bevacizumab
5 mg/kg at each cycle in intravenous
Other Names:
  • Beva
Drug: 5 FU continuous
2400 mg/m² intravenously over 46 hours
Other Names:
  • 5 FU
Drug: Oxaliplatin intravenous
85 mg/m² in intravenous. 1 cycle each 15 days
Other Names:
  • Oxaliplatin IV
Drug: Irinotecan
150 mg/m² intravenous
Other Names:
  • IRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 24 months after randomization
comparison of radiological/clinical progression free survival
24 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Julien TAIEB, MD-PhD, HEGP, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimated)

August 31, 2016

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

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  • PRODIGE 49

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Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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