Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Federation Francophone de Cancerologie Digestive (Voir sur ClinicalTrials)
décembre 2016
septembre 2027
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 04/02/2024 16:34:20 | Contacter | ||
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 23/12/2024 08:04:13 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Romain CORIAT | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Julien TAIEB | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Isabelle BAUMGAERTNER, Dr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Paul Brousse | Mohamed BOUCHAHDA | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Romain COHEN, Dr | Contact (sur clinicalTrials) | |||
| CENTRE HOSPITALIER SUD FRANCILIEN | Samy LOUAFI | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Hugues BLONDON, Dr | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT CURIE | Bruno BUECHER, Dr | Contact (sur clinicalTrials) | |||
| CPEF LEVALLOIS PERRET | Benoist CHIBAUDEL, Dr | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Nabil BABA-HAMED | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Radiothérapie Pierre Curie - 62660 - Beuvry - France | Aurélie FADIN, Dr | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Stéphane CORBINAIS, Dr | Contact (sur clinicalTrials) | |||
| Centre Georges-François Leclerc - 21079 - Dijon - France | François GHIRINGHELLI, Pr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier du pays d'Aix - 13616 - Aix-en-Provence - France | Sophie NAHON BRISSONNEAU, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Métropole Savoie - 73011 - Chambéry CEDEX - France | Olivier BERTHELET, Dr | Contact (sur clinicalTrials) | |||
| Ch - Chd Vendee - La Roche Sur Yon - France | Margot LALY | Contact (sur clinicalTrials) | |||
| CH D'Abbeville - 80142 - Abbeville CEDEX - France | Mathieu PAUWELS, Dr | Contact (sur clinicalTrials) | |||
| CH de Beauvais - 60021 - Beauvais - France | Fayçal HOCINE, Dr | Contact (sur clinicalTrials) | |||
| CH Jean Minjoz - 25030 - Besançon - France | Stéfano KIM, Dr | Contact (sur clinicalTrials) | |||
| CH William Morey - 71100 - Chalon-sur-Saône - France | Laurie RAMBACH, Dr | Contact (sur clinicalTrials) | |||
| CHU - Hôpital François Mitterand - Dijon - France | Sylvain MANFREDI | Contact (sur clinicalTrials) | |||
| Clinique Saint Côme - 60204 - Compiègne CEDEX - France | Kaïs ALDABBAGH, Dr | Contact (sur clinicalTrials) | |||
| CMC Les Ormeaux - 76600 - Le Havre - France | Gilles PIOT, Dr | Contact (sur clinicalTrials) | |||
| CMCO Côte d'Opale - 62222 - Boulogne-sur-Mer - France | Laurent GASNAULT, Dr | Contact (sur clinicalTrials) | |||
| GHM Institut Daniel Hollard - 38028 - Grenoble CEDEX 1 - France | Christine REBISCHUNG, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Duchenne - 62321 - Boulogne-sur-Mer - France | Vincent BOURGEOIS, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé Sainte Marie - 71100 - Chalon-sur-Saône - France | Erika VIEL, Dr | Contact (sur clinicalTrials) | |||
| Hopitaux Civils de Colmar - 68024 - Colmar - France | Gilles BREYSACHER, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Bourgogne - GRRECC - 21000 - Dijon - France | Ariane DARUT-JOUVE, Dr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CAC - Eugène Marquis - Rennes - France | Samuel LE SOURD | Contact (sur clinicalTrials) | |||
| CAC - ICO Site René Gauducheau - Saint-Herblain - France | Véronique GUERIN-MEYER | Contact (sur clinicalTrials) | |||
| CAC - Léon Bernard - Lyon - France | Matthieu SARABI | Contact (sur clinicalTrials) | |||
| Centre d'Imagerie médicale du Confluent- IRIS GRIM - Nantes - France | Jean-Marie PASQUIER | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 26216 - Montélimar - France | Agnès PELAQUIER, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 71300 - Montceau-les-Mines - France | Patricia GABEZ, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Saint Malo - 35403 - Saint-Malo - France | Romain DESGRIPPES, Dr | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - 67065 - Strasbourg - France | Meher BEN ABDELGHANI, Dr | Contact (sur clinicalTrials) | |||
| CH - 02209 - Soissons CEDEX - France | Sarah MONTEMBAULT, Dr | Contact (sur clinicalTrials) | |||
| CH - 60309 - Senlis CEDEX - France | Elisabeth CAROLA, Dr | Contact (sur clinicalTrials) | |||
| CH - Centre Hospitalier de Pau - 64046 - Pau - France | Juliette THAURY, Dr | Contact (sur clinicalTrials) | |||
| CH - Côte Basque - 64109 - Bayonne CEDEX - France | Franck AUDEMAR, Dr | Contact (sur clinicalTrials) | |||
| CH - Pau - Pau - France | Mireille SIMON | Contact (sur clinicalTrials) | |||
| CH - Perpignan - France | Faiza KHEMISSA AKOUZ | Contact (sur clinicalTrials) | |||
| CH - Saint Joseph - Marseille - France | Hervé PERRIER | Contact (sur clinicalTrials) | |||
| CH Annecy Genevois - 74374 - Pringy - France | Mathieu BACONNIER, Dr | Contact (sur clinicalTrials) | |||
| CH d'Auxerre - 89000 - Auxerre - France | Anne-Laure VILLING, Dr | Contact (sur clinicalTrials) | |||
| CH de Meaux - 77100 - Meaux - France | Christophe LOCHER, Dr | Contact (sur clinicalTrials) | |||
| CH du Mans - 72037 - Le Mans CEDEX 9 - France | Oana COJOCARASU, Dr | Contact (sur clinicalTrials) | |||
| CH Lyon Sud - 69495 - Pierre-Bénite CEDEX - France | Marion CHAUVENET, Dr | Contact (sur clinicalTrials) | |||
| CH Marne La Vallée-Jossigny - Hôpital André Mignot - 77600 - Jossigny - France | Christine LE FOLL, Dr | Contact (sur clinicalTrials) | |||
| CH René Dubois - 95300 - Pontoise - France | Sophie MANET-LACOMBE, Dr | Contact (sur clinicalTrials) | |||
| CHIC - 29000 - Quimper - France | Karine BIDEAU, Dr | Contact (sur clinicalTrials) | |||
| CHR - Orleans - France | Jean-Paul LAGASSE | Contact (sur clinicalTrials) | |||
| CHU - Haut Lévêque - Pessac - France | Denis SMITH | Contact (sur clinicalTrials) | |||
| Chu - Hopital Nord Chu Saint Etienne - Saint-Priest-en-Jarez - France | Jean-Marc PHELIP | Contact (sur clinicalTrials) | |||
| CHU - Hôtel Dieu - Angers - France | Antoine HAMY | Contact (sur clinicalTrials) | |||
| CHU - Hôtel Dieu - Nantes - France | Yann TOUCHEFEU | Contact (sur clinicalTrials) | |||
| CHU - Poitiers - France | David TOUGERON | Contact (sur clinicalTrials) | |||
| CHU - Rangueil - Toulouse - France | Rosine GUIMBAUD | Contact (sur clinicalTrials) | |||
| CHU - Saint Louis - Paris - France | Thomas APARICIO | Contact (sur clinicalTrials) | |||
| CHU Charles Nicolle - 76031 - Rouen CEDEX 01 - France | Frédéric DI FIORE, Pr | Contact (sur clinicalTrials) | |||
| CHU de Pont Chaillou - 35033 - Rennes CEDEX 9 - France | Astrid LIEVRE, Pr | Contact (sur clinicalTrials) | |||
| CHU de Saint Etienne - Hôpital Nord - 42270 - Saint-Priest-en-Jarez - France | Jean-Marc PHELIP, Pr | Contact (sur clinicalTrials) | |||
| CHU La Timone - 13385 - Marseille CEDEX 5 - France | Laétitia DAHAN, Pr | Contact (sur clinicalTrials) | |||
| CHU Nancy-Brabois - 54511 - Vandœuvre-lès-Nancy - France | Anthony LOPEZ, Dr | Contact (sur clinicalTrials) | |||
| CHU Robert Debré - 51092 - Reims CEDEX - France | Olivier BOUCHE, Pr | Contact (sur clinicalTrials) | |||
| Clinique Mutualiste de l'Estuaire - Cité Sanitaire - 44600 - Saint Nazaire - France | Catherine LIGEZA POISSON, Dr | Contact (sur clinicalTrials) | |||
| Clinique Trenel - 69560 - Sainte Colombe - France | Ivan GRABER, Dr | Contact (sur clinicalTrials) | |||
| Hôpial Privé du Confluent Le Confluent Centre Catherine de Sienne - Nantes - France | Hélène CASTANIE | Contact (sur clinicalTrials) | |||
| Hôpital Belle Isle - 57000 - Metz - France | Jérôme PLAZA, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de Bicêtre - 94270 - Le Kremlin-Bicêtre - France | Emilie SOULARUE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Drome Nord - 26100 - Romans-sur-Isère - France | Marie-Claude GOUTTEBEL, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - 69437 - Lyon - France | Julien FORESTIER, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Louis Pasteur - 28018 - Chartres - France | Laëtitia RAJPAR, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé d'Antony - 92166 - Antony - France | Anne THIROT-BIDAULT, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Sainte Musse - 83000 - Toulon - France | Pierre GUILLET, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Sud - 80054 - Amiens - France | Jean Marc REGIMBEAU | Contact (sur clinicalTrials) | |||
| Hôpitaux du Leman - 74203 - Thonon-les-Bains - France | Khoutir MAHOUR BACHA, Dr | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux CEDEX - France | Dominique BECHADE, Pr | Contact (sur clinicalTrials) | |||
| Institut de cancérologie de Lorraine - 54519 - Vandœuvre-lès-Nancy - France | Pierre LEHAIR, Dr | Contact (sur clinicalTrials) | |||
| Polyclinique Francheville - 24004 - Périgueux - France | Laurent CANY, Dr | Contact (sur clinicalTrials) | |||
| PRIVE - Hôpital Européen - Marseille - France | Yves RINALDI | Contact (sur clinicalTrials) | |||
| PRIVE - Infirmerie Protestante de Lyon - 69300 - Caluire-et-Cuire - France | Johannes HARTWIG, Dr | Contact (sur clinicalTrials) | |||
| PRIVE - Polyclinique Bordeaux Nord - Bordeaux - France | Cédric LECAILLE | Contact (sur clinicalTrials) | |||
| PRIVE - Saint Grégoire - Saint-Grégoire - France | Laurent MIGLIANICO | Contact (sur clinicalTrials) | |||
| PRIVE - Sainte Catherine - Avignon - France | Laurent MINEUR | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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