Colorectal NeoplasmsPhase 3OSCARNCT02885753
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
A Phase 3 study testing Oxaliplatin intravenous, 5 FU bolus and Folinic acid in people with Colorectal Neoplasms, run by Federation Francophone de Cancerologie Digestive at 49 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Oxaliplatin intravenous, 5 FU bolus and Folinic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 49 sitesin 2 countries
- Study dates
- Dec 2016to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
49 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
49 sites in 2 countries
France48 sites, 48 recruiting
- Recruiting
Chu Hotel Dieu
Angers
Antoine BOUVIER, 02 41 35 35 03, anbouvier@chu-angers.fr
- Recruiting
Institut de Cancérologie de l'Ouest
Angers
- Recruiting
Hôpital Privé d'Antony
Antony
Anne THIROT-BIDAULT, 01 46 74 41 73, a.t.bidault@gmail.com
- Not yet recruiting
CH Henri Duffaut
Avignon
Adam VODNAR, vodnar.adam@ch-avignon.fr
- Recruiting
Institut du cancer Avignon Provence
Avignon
Laurent MINEUR, 04 90 27 61 81, l.mineur@isc84.org
- Recruiting
Ch Cote Basque
Bayonne
Franck AUDEMAR, 0559443722, faudemar@ch-cotebasque.fr
- Recruiting
Clinique Belharra
Bayonne
Marjorie FAURE, 0554614010, marjorie.faure@copb.eu
- Not yet recruiting
Centre Hospitalier
Beauvais
Hanifa AMMARGUELLAT, 03 44 11 21 22, h.ammarguellat@ch-beauvais.fr
- Recruiting
Institut Bergonié
Bordeaux
Simon PERNOT, 05 56 33 32 78, simon.pernot@gmail.com
- Recruiting
Polyclinique Bordeaux Nord
Bordeaux
Cédric LECAILLE, 0556690681, lecail@hotmail.com
- Recruiting
Infirmerie Protestante de Lyon
Caluire-et-Cuire
Johannes HARTWIG, 04 72 00 71 67, johannes.hartwig@infirmerie-protestante.com
- Not yet recruiting
CH Loire Vendée Océan
Challans
Margot LALY, 02 51 44 61 68, margot.laly@ght85.fr
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
Samy LOUAFI, 0161693077, samy.louafi@gmail.com
- Not yet recruiting
Chu Le Bocage
Dijon
Sylvain MANFREDI, 0380293750, sylvain.manfredi@chu-dijon.fr
- Recruiting
Chd Vendee
La Roche-sur-Yon
Margot LALY, 02 51 44 61 68, margot.laly@ght85.fr
- Recruiting
Groupe Hospitalier de la Rochelle Re-Aunis
La Rochelle
Valérie MOULIN, 05 46 45 88 67
- Not yet recruiting
Ch de Bicetre
Le Kremlin-Bicêtre
Lysiane MARTHEY, 01 45 21 37 20, lysiane.marthey@gmail.com
- Not yet recruiting
GH Nord Essone
Longjumeau
Samy LOUAFI
- Recruiting
Hôpital du Scorff
Lorient
Florence LE ROY, 02 97 06 95 20, f.leroy@ghbs.bzh
- Recruiting
Centre Léon Bérard
Lyon
Pauline ROCHEFORT, 04 6985 60 23, pauline.rochefort@lyon.unicancer.fr
- Recruiting
Hôpital de la Croix Rousse
Lyon
Marielle GUILLET, 04 26 73 28 88, marielle.guillet@chu-lyon.fr
- Recruiting
Hôpital Européen
Marseille
Yves RINALDI, 0380293750, yrinaldi@wanadoo.fr
- Recruiting
Hôpital Saint-Joseph
Marseille
Hervé PERRIER, 0491808211, hperrier@hopital-saint-joseph.fr
- Not yet recruiting
Institut Paoli Calmettes
Marseille
Elika LOIR, 04 91 22 37 40, loire@ipc.unicancer.fr
- Recruiting
Chu Hotel Dieu
Nantes
Yann TOUCHEFEU, 02 40 08 31 52, yann.touchefeu@chu-nantes.fr
- Not yet recruiting
CHR La Source
Orléans
Jean-Paul LAGASSE, 02 38 51 47 04, jean-paul.lagasse@chr-orleans.fr
- Not yet recruiting
Hôpital Cochin
Paris
Romain CORIAT, 01 58 41 19 52, romain.coriat@aphp.fr
- Recruiting
Hôpital Saint Joseph
Paris
Nabil BABA HAMED, 0144126888, nbaba-hamed@hpsj.fr
- Recruiting
Hôpital Saint Louis
Paris
Thomas APARICIO, 01 42 49 95 97, thomas.aparicio@aphp.fr
- Recruiting
Paris Hôpital Européen Georges Pompidou
Paris
Julien TAIEB, jtaieb75@gmail.com, jtaieb75@gmail.com
- Recruiting
Centre Hospitalier
Pau
Mireille SIMON, 05 59 92 49 83, mireille.simon@ch-pau.fr
- Recruiting
Centre Hospitalier Saint Jean
Perpignan
Faiza KHEMISSA, 0468616137, fkhemissa@hotmail.com
- Recruiting
CHU Haut Lévêque
Pessac
Denis SMITH, 05 57 65 64 39, denis.smith@chu-bordeaux.fr
- Recruiting
CHU La Milétrie
Poitiers
David TOUGERON, 05 49 44 37 51, david.tougeron@chu-poitiers.fr
- Recruiting
Centre Eugène Marquis
Rennes
Samuel LE SOURD, 02 99 25 31 96, s.lesourd@rennes.unicancer.fr
- Not yet recruiting
Clinique Pasteur
Ris-Orangis
Aroun Ali KHALFALLAH, 01 69 25 68 17, khalfallah.haroun@yahoo.fr
- Not yet recruiting
CROME
Ris-Orangis
Wassim KHODARI, 01 69 02 10 65, wassim.khodari@le-crome.fr
- Recruiting
CHU Charles Nicolle
Rouen
Frédéric DI FIORE, 02 32 88 64 56, Frederic.Di-Fiore@chu-rouen.fr
- Recruiting
CHP
Saint-Grégoire
Edith CARTON, 02 90 09 44 66, edith.carton@icrb.fr
- Recruiting
Institut de cancérologie de l'Ouest
Saint-Herblain
- Recruiting
CHU Saint-Etienne
Saint-Priest-en-Jarez
Jean-Marc PHELIP, 04 77 82 86 19, j.marc.phelip@chu-st-etienne.fr
- Recruiting
Hôpital FOCH
Suresnes
Asmahane BENMAZIANE TEILLET, 01 46 25 28 64, basmahane@gmail.com
- Not yet recruiting
Maison de Santé Protestante de Bordeaux Bagatelle
Talence
Julien VERGNIOL, 05 57 12 35 26, julienvergniol@hotmail.com
- Recruiting
Hia Sainte Anne
Toulon
Caroline PRIEUX-KLOTZ, 04 83 16 25 19, prieuxcaroline@gmail.com
- Recruiting
Chu Toulouse Rangueil
Toulouse
Rosine GUIMBAUD, 05 61 32 27 41, guimbaud.r@chu-toulouse.fr
- Not yet recruiting
Clinique Pasteur
Toulouse
Mathilde MARTINEZ, 05 67 20 44 01, m.martinez@clinique-pasteur.com
- Not yet recruiting
Hôpital Paul Brousse
Villejuif
Mohamed BOUCHAHDA
- Recruiting
Institut Gustave Roussy
Villejuif
Michel DUCREUX, 0142114308, michel.ducreux@gustaveroussy.fr
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Erasme
Brussels
Gontran VERSET, 0032 2 555 37 12, gontran.verset@hubruxelles.be
About this study
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
- Colorectal Neoplasms
- Being tested
- Oxaliplatin intravenous, 5 FU bolus, Folinic acid, Oxaliplatin intra-arteriel, Panitumumab
- Keywords
- colorectal, cancer, metastasis, hepatic
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin intravenousDrug
Also called Oxaliplatin IV
85 mg/m² in intravenous. 1 cycle each 15 days
5 FU bolusDrug
Also called 5 FU
5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous
Folinic acidDrug
Also called Folinic Acid IV
400 mg/m² in intravenous
Oxaliplatin intra-arterielDrug
Also called Oxaliplatin IA
85 mg/m² in intra-arterial. 1 cycle each 15 days
PanitumumabDrug
Also called Pani
Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous
BevacizumabDrug
Also called Beva
5 mg/kg at each cycle in intravenous
5 FU continuousDrug
Also called 5 FU
2400 mg/m² intravenously over 46 hours
IrinotecanDrug
Also called IRI
150 mg/m² intravenous
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status | Experimental | 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 Receives: Drug: 5 FU bolus; Drug: Folinic acid; Drug: Oxaliplatin intra-arteriel; Drug: Panitumumab; Drug: Bevacizumab; Drug: 5 FU continuous |
| Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status | Active comparator | 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 Receives: Drug: Oxaliplatin intravenous; Drug: 5 FU bolus; Drug: Folinic acid; Drug: Panitumumab; Drug: Bevacizumab; Drug: 5 FU continuous |
| Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab | Experimental | 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 Receives: Drug: Folinic acid; Drug: Oxaliplatin intra-arteriel; Drug: Bevacizumab; Drug: 5 FU continuous; Drug: Irinotecan |
| Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab | Active comparator | 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 Receives: Drug: Oxaliplatin intravenous; Drug: Folinic acid; Drug: Bevacizumab; Drug: 5 FU continuous; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
comparison of radiological/clinical progression free survival
Measured: 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien TAIEB, MD-PhD, Principal investigator, HEGP, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885753
- Sponsor's protocol ID
- PRODIGE 49
- Acronym
- OSCAR
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2016
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 35027324
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02885753
- Acronym / sponsor ID
- OSCAR / PRODIGE 49
- Conditions
- Colorectal Neoplasms
- Keywords
- colorectal, cancer, metastasis, hepatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status | Experimental | Drug: 5 FU bolus, Drug: Folinic acid, Drug: Oxaliplatin intra-arteriel, Drug: Panitumumab, Drug: Bevacizumab, Drug: 5 FU continuousPanitumumab (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 |
| Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status | Active comparator | Drug: Oxaliplatin intravenous, Drug: 5 FU bolus, Drug: Folinic acid, Drug: Panitumumab, Drug: Bevacizumab, Drug: 5 FU continuousPanitumumab (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 |
| Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab | Experimental | Drug: Folinic acid, Drug: Oxaliplatin intra-arteriel, Drug: Bevacizumab, Drug: 5 FU continuous, Drug: IrinotecanBevacizumab (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 |
| Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab | Active comparator | Drug: Oxaliplatin intravenous, Drug: Folinic acid, Drug: Bevacizumab, Drug: 5 FU continuous, Drug: IrinotecanBevacizumab (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxaliplatin intravenousAlso: Oxaliplatin IV85 mg/m² in intravenous. 1 cycle each 15 days | Drug | Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status, Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab |
| 5 FU bolusAlso: 5 FU5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous | Drug | Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status, Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status |
| Folinic acidAlso: Folinic Acid IV400 mg/m² in intravenous | Drug | Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status, Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab, Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status, Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab |
| Oxaliplatin intra-arterielAlso: Oxaliplatin IA85 mg/m² in intra-arterial. 1 cycle each 15 days | Drug | Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status, Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab |
| PanitumumabAlso: PaniOnly for patient RAS wild: 6 mg/Kg at each cycle in intravenous | Drug | Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status, Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status |
| BevacizumabAlso: Beva5 mg/kg at each cycle in intravenous | Drug | Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status, Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab, Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status, Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab |
| 5 FU continuousAlso: 5 FU2400 mg/m² intravenously over 46 hours | Drug | Experimental arm FOLFOX with oxaliplatin intraarterial + targeted therapy to RAS status, Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab, Reference arm FOLFOX with oxaliplatin intravenous + targeted therapy to RAS status, Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab |
| IrinotecanAlso: IRI150 mg/m² intravenous | Drug | Experimental arm mFOLFIRINOX with oxaliplatin intraarterial + Bevacizumab, Reference arm mFOLFIRINOX with oxaliplatin intravenous + Bevacizumab |
Primary outcome
progression-free survival
Time frame: 24 months after randomization
comparison of radiological/clinical progression free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 35027324Pernot 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.
- Individual participant dataSharing planned: Undecided
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Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien TAIEB, MD-PhD principal investigator
HEGP, Paris
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxaliplatin intravenous, 5 FU bolus and Folinic acid in people with Colorectal Neoplasms, run by Federation Francophone de Cancerologie Digestive at 49 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia JOURDAN (+33 (0)380393404, sofia.jourdan@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 24 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02885753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.