FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation
OPTIPRIME
A Phase II Study Evaluating FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation
1 other identifier
interventional
118
2 countries
124
Brief Summary
Single-arm, multi-centre phase II study The primary objective is to evaluate the time to failure of the strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2018
Longer than P75 for phase_2
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2018
CompletedFirst Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2025
CompletedJune 29, 2025
June 1, 2025
6.9 years
June 19, 2018
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to failure of the strategy
Time to strategy Failure is defined as the time from date of inclusion to strategy failure (Radiological progression under treatment or death or definitive treatment discontinuation or recurrence after curative surgery with or without adjuvant treatment)
Up to 20 months
Study Arms (1)
FOLFOX + panitumumab
EXPERIMENTAL1 cylce every 14 days : Panitumumab : 6 mg/kg en IV (J1) during 60 minutes for 1st infusion followed by 30 to 60 minutes Oxaliplatine : 85 mg/m² inG5% orNaCl 0.9% in IV (D1) during 2 hours Acide folinique : 400 mg/m² (or200 mg/m² if Elvorine) in IV (D1) 5Fu bolus : 400 mg/m² in IV 5FU continu : 2400 mg/m² in IV during 46 hours LV5FU2 : 1 cycle every 14 days Acide folinique : 400 mg/m² (or 200 mg/m² ifElvorine) in IV (D1) during 2 hours 5FU bolus : 400 mg/m² in IV 5FU continu : 2400 mg/m² in IV during 46 hours
Interventions
FOLFOX + panitumumab according to a "stop and go" strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment
Eligibility Criteria
You may qualify if:
- \- Histologically proven colorectal adenocarcinoma without RAS mutation
- Confirmed, non-resectable metastatic disease (Stage IV)
- No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
- At least one measurable metastasis according to the RECIST v1.1 criteria
- Age ≥ 18 years
- WHO ≤ 2
- Neutrophils \> 1500 /mm3, platelets\> 100 000/mm3, Hb \> 9 g/dL
- Creatinine clearance \> 50 mL/min according to the MDRD formula
- Serum bilirubin \< 25 µmol/L, AST, ALT, Alk Phos \< 2.5 x ULN or \< 5 x ULN in case of liver metastases
- PT \> 60%, albumin ≥ 25g/L
- Estimated life expectancy ≥ 3 months
- Patient affiliated to a social security scheme
- Patient informed and informed consent form signed
You may not qualify if:
- \- Presence of uncontrolled symptomatic brain metastases
- RAS mutation (KRAS or NRAS mutation)
- Known DPD deficiency
- Peripheral neuropathy \> 1 (NCI CTCAE v4.0)
- Patient with interstitial pneumonitis or pulmonary fibrosis
- History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment
- Poorly controlled chronic skin disease
- Any known specific contraindication or allergy to the medicinal products used in the study
- Patient simultaneously included in another clinical trial involving an investigational drug (example: chemotherapy, targeted therapy, immunotherapy)
- Arterial hypertension not controlled by medical treatment (Systolic BP ≥ 160 mmHg end/or diastolic BP ≥ 90 mmHg)
- Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
- Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes
- History of malignant pathologies during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated
- QT/QTc interval \> 450 msec for men and \> 470 msec for women
- K+ \< LNL, Mg2+ \< LNL, Ca2+ \< LNL
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federation Francophone de Cancerologie Digestivelead
- Amgencollaborator
Study Sites (124)
Clinique Trenel
Sainte-Colombe, Lyon, 69560, France
Clinique Claude Bernard
Albi, 81030, France
Clinique Claude Bernard
Albi, France
Hopital Sud
Amiens, 80054, France
Clinique de L'Europe
Amiens, 80090, France
CHU Amiens Picardie Hôpital Sud
Amiens, France
Clinique de l'Europe
Amiens, France
Chu D'Angers
Angers, 49933, France
CHU
Angers, France
Hopital Prive D'Antony
Antony, 92166, France
Hôpital Privé
Antony, France
Centre Marie Curie
Arras, 62000, France
Hopital Les Bonnettes
Arras, 62012, France
Centre Marie Curie
Arras, France
Hôpital Privé Les Bonnettes
Arras, France
CH Henri Duffaut
Avignon, France
Institut Sainte Catherine
Avignon, France
Ch Cote Basque
Bayonne, 64109, France
Centre Hospitalier Côte Basque
Bayonne, France
Ch de Beauvais
Beauvais, 60021, France
Centre Hospitalier
Beauvais, France
Ch de Beziers Cedex
Béziers, 34525, France
Centre Hospitalier
Béziers, France
Polyclinique Saint Privat
Boujan-sur-Libron, 34760, France
Cmco Cote D'Opale
Boulogne-sur-Mer, 62222, France
Hopital Duchenne
Boulogne-sur-Mer, 62321, France
Hôpital Duchenne
Boulogne-sur-Mer, France
Hopital Morvan - Chu
Brest, 29609, France
CHU
Brest, France
Centre Francois Baclesse
Caen, 14076, France
Centre François Baclesse
Caen, France
Ch Cahors
Cahors, 46000, France
Loire Vendee Ocean
Challans, France
Hôpital Louis Pasteur
Chartres, France
Centre Hospitalier General
Châlons-en-Champagne, 51005, France
Centre Hospitalier
Châlons-en-Champagne, France
Ch de Cholet
Cholet, 49325, France
Centre Hospitalier
Cholet, France
Hopitaux Civils de Colmar
Colmar, 68024, France
Hôpitaux Civils de Colmar
Colmar, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Clinique de Flandre
Coudekerque-Branche, France
Service de Medecine
Digne-les-Bains, 04000, France
Centre Hospitalier
Digne-les-Bains, France
Centre G. François Leclerc
Dijon, France
CHU
Dijon, France
CH
Dunkirk, 59385, France
Centre Hospitalier
Dunkirk, France
Hopital Jacques Monod
Flers, 61104, France
CH J Monod
Flers, France
CHU Martanique Hôpital Clarac
FORT de France, France
Chi de Frejus Saint-Raphael
Fréjus, 83600, France
CHI Fréjus St Raphaël
Fréjus, France
Hôpital Michallon
Grenoble, France
Polyclinique de Blois - 3Eme Etage
La Chaussée-Saint-Victor, 41260, France
Polyclinique Blois
La Chaussée-Saint-Victor, France
Chd Vendee
La Roche-sur-Yon, 85925, France
CHD VENDEE (Les Oudairies)
La Roche-sur-Yon, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Ch Du Mans
Le Mans, 72037, France
Centre Hospitalier
Le Mans, France
Centre Hospitalier Schaffner
Lens, 62307, France
Centre Hospitalier
Lens, France
Chru Hopital Claude Huriez 4Eme Est
Lille, 59037, France
CHU Claude Huriez
Lille, France
Hôpital Privé LE BOIS
Lille, France
Ch St Joseph-St Luc
Lyon, 69365, France
CH Saint Joseph St Luc
Lyon, France
Prive - Jean Mermoz
Lyon, France
Chi F. Quesnay
Mantes-la-Jolie, France
Hopital Europeen Marseille
Marseille, 13331, France
Hôpital Européen
Marseille, France
Ch de Meaux
Meaux, 77100, France
Centre Hospitalier
Meaux, France
Hopital Layne
Mont-de-Marsan, 40024, France
Centre Hospitalier
Montélimar, France
CHI
Montfermeil, France
Polyclinique de Gentilly
Nancy, 54100, France
Centre d'oncologie de Gentilly
Nancy, France
Hopital Prive Du Confluent Sas
Nantes, 44277, France
Le Confluent SAS
Nantes, France
Ch de Niort - Sce D'Oncologie
Niort, 79021, France
Centre Hospitalier
Niort, France
CHR
Orléans, France
Chu Cochin
Paris, 75014, France
Groupe Hospitalier Pitie-Salpetriere
Paris, 75651, France
CHU Bichat
Paris, France
Groupe Diaconnesses Croix St Simon
Paris, France
Groupe Hospitalier Pitie-Salpetriere
Paris, France
HEGP
Paris, France
Hôpital Cochin (APHP)
Paris, France
La Pitie Salpetriere
Paris, France
Hôpital Haut Lévêque
Pessac, France
Centre Hospitalier
Périgueux, France
Polyclinique Francheville
Périgueux, France
CHU
Poitiers, France
Clinique de la Croix du Sud
Quint-Fonsegrives, France
Polyclinique de Courlancy
Reims, 51100, France
Institut du Cancer Courlancy
Reims, France
CH de Romans
Romans-sur-Isère, France
Centre Hospitalier
Roubaix, France
CHU
Rouen, France
Saint Hilaire - Privee
Rouen, France
CHP
Saint-Grégoire, France
Clinique de l'Union
Saint-Jean, France
Centre Médical Côte d'Opale
Saint-Martin-Boulogne, France
Hopital Nord Chu Saint Etienne
Saint-Priest-en-Jarez, France
Centre Hospitalier
Saint-Quentin, 02321, France
Centre Hospitalier
Saint-Quentin, France
Clinique Trenel
Sainte-Colombe, France
Clinique Charcot
Sainte-Foy-lès-Lyon, France
Clinique Ste Anne
Strasbourg, 67000, France
Centre Paul Strauss
Strasbourg, 67065, France
Centre Paul Strauss
Strasbourg, France
Clinique Sainte Anne
Strasbourg, France
Polyclinique de L'Ormeau
Tarbes, 65000, France
Hôpital Sainte Musse
Toulon, France
Clinique Pasteur
Toulouse, 31076, France
Clinique Pasteur
Toulouse, France
CHRU
Tours, France
Clinique des Dentellières
Valenciennes, France
Hôpital Privé
Villeneuve-d'Ascq, France
Médipôle Hôpital Mutualiste Lyon Villeurbanne
Villeurbanne, France
Chu de Fort de France
Fort-de-France, 97261, Martinique
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Baptiste Bachet, Pr
Federation Francophone de Cancerologie Digestive
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2018
First Posted
July 12, 2018
Study Start
April 26, 2018
Primary Completion
March 30, 2025
Study Completion
March 30, 2025
Last Updated
June 29, 2025
Record last verified: 2025-06