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
NCT ID: NCT02885753
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
348 participants
INTERVENTIONAL
2016-12-31
2028-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
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
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
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
Folinic acid
400 mg/m² in intravenous
Oxaliplatin intra-arteriel
85 mg/m² in intra-arterial. 1 cycle each 15 days
Bevacizumab
5 mg/kg at each cycle in intravenous
5 FU continuous
2400 mg/m² intravenously over 46 hours
Irinotecan
150 mg/m² intravenous
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
Oxaliplatin intravenous
85 mg/m² in intravenous. 1 cycle each 15 days
Folinic acid
400 mg/m² 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Julien TAIEB, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
HEGP, Paris
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Valérie MOULIN
Role: primary
Samy LOUAFI
Role: primary
Mohamed BOUCHAHDA
Role: primary
References
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Pernot S, Pellerin O, Mineur L, Monterymard C, Smith D, Lapuyade B, Gallois C, Khemissa Akouz F, De Baere T, Tougeron D, Thirot-Bidault A, Audemar F, Simon M, Lecaille C, Louafi S, Lepage C, Ducreux M, Taieb J. Phase III randomized trial comparing systemic versus intra-arterial oxaliplatin, combined with LV5FU2 +/- irinotecan and a targeted therapy, in the first-line treatment of metastatic colorectal cancer restricted to the liver (OSCAR): PRODIGE 49. Dig Liver Dis. 2022 Mar;54(3):324-330. doi: 10.1016/j.dld.2021.12.012. Epub 2022 Jan 11.
Other Identifiers
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PRODIGE 49
Identifier Type: -
Identifier Source: org_study_id
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