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 2028
10 juillet 2025
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 | ||
| 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 Paul Brousse | Mohamed BOUCHAHDA | Contact (sur clinicalTrials) | |||
| CENTRE HOSPITALIER SUD FRANCILIEN | Samy LOUAFI | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Nabil BABA HAMED | 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 | |||||
| Centre Eugène Marquis - Rennes - France | Samuel LE SOURD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - Beauvais - France | Hanifa AMMARGUELLAT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - Pau - France | Mireille SIMON | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Saint Jean - Perpignan - France | Faiza KHEMISSA | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Pauline ROCHEFORT | Contact (sur clinicalTrials) | |||
| Ch Cote Basque - Bayonne - France | Franck AUDEMAR | Contact (sur clinicalTrials) | |||
| Ch de Bicetre - Le Kremlin-Bicêtre - France | Lysiane MARTHEY | Contact (sur clinicalTrials) | |||
| CH Henri Duffaut - Avignon - France | Adam VODNAR | Contact (sur clinicalTrials) | |||
| CH Loire Vendée Océan - Challans - France | Margot LALY | Contact (sur clinicalTrials) | |||
| Chd Vendee - La Roche-sur-Yon - France | Margot LALY | Contact (sur clinicalTrials) | |||
| CHP - Saint-Grégoire - France | Edith CARTON | Contact (sur clinicalTrials) | |||
| CHR La Source - Orléans - France | Jean-Paul LAGASSE | Contact (sur clinicalTrials) | |||
| CHU Charles Nicolle - Rouen - France | Frédéric DI FIORE | Contact (sur clinicalTrials) | |||
| CHU Haut Lévêque - Pessac - France | Denis SMITH | Contact (sur clinicalTrials) | |||
| Chu Hotel Dieu - Angers - France | Antoine BOUVIER | Contact (sur clinicalTrials) | |||
| Chu Hotel Dieu - Nantes - France | Yann TOUCHEFEU | Contact (sur clinicalTrials) | |||
| CHU La Milétrie - Poitiers - France | David TOUGERON | Contact (sur clinicalTrials) | |||
| Chu Le Bocage - Dijon - France | Sylvain MANFREDI | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne - Saint-Priest-en-Jarez - France | Jean-Marc PHELIP | Contact (sur clinicalTrials) | |||
| Chu Toulouse Rangueil - Toulouse - France | Rosine GUIMBAUD | Contact (sur clinicalTrials) | |||
| Clinique Belharra - Bayonne - France | Marjorie FAURE | Contact (sur clinicalTrials) | |||
| Clinique Pasteur - Ris-Orangis - France | Aroun Ali KHALFALLAH | Contact (sur clinicalTrials) | |||
| Clinique Pasteur - Toulouse - France | Mathilde MARTINEZ | Contact (sur clinicalTrials) | |||
| CROME - Ris-Orangis - France | Wassim KHODARI | Contact (sur clinicalTrials) | |||
| GH Nord Essone - Longjumeau - France | Samy LOUAFI | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier de la Rochelle Re-Aunis - La Rochelle - France | Valérie MOULIN | Contact (sur clinicalTrials) | |||
| Hia Sainte Anne - Toulon - France | Caroline PRIEUX-KLOTZ | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse - Lyon - France | Marielle GUILLET | Contact (sur clinicalTrials) | |||
| Hôpital du Scorff - Lorient - France | Florence LE ROY | Contact (sur clinicalTrials) | |||
| Hôpital Européen - Marseille - France | Yves RINALDI | Contact (sur clinicalTrials) | |||
| Hôpital FOCH - Suresnes - France | Asmahane BENMAZIANE TEILLET | Contact (sur clinicalTrials) | |||
| Hôpital Privé d'Antony - Antony - France | Anne THIROT-BIDAULT | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis - Paris - France | Thomas APARICIO | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Joseph - Marseille - France | Hervé PERRIER | Contact (sur clinicalTrials) | |||
| Infirmerie Protestante de Lyon - Caluire-et-Cuire - France | Johannes HARTWIG | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Simon PERNOT | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut de cancérologie de l'Ouest - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut du cancer Avignon Provence - Avignon - France | Laurent MINEUR | Contact (sur clinicalTrials) | |||
| Institut Gustave Roussy - Villejuif - France | Michel DUCREUX | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Elika LOIR | Contact (sur clinicalTrials) | |||
| Maison de Santé Protestante de Bordeaux Bagatelle - Talence - France | Julien VERGNIOL | Contact (sur clinicalTrials) | |||
| Polyclinique Bordeaux Nord - Bordeaux - France | Cédric LECAILLE | 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