First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem
PANOPTIMOX
Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line
1 other identifier
interventional
276
1 country
54
Brief Summary
The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy. Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin. These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years. FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment. The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2015
Longer than P75 for phase_2
54 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
January 12, 2015
CompletedFirst Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedResults Posted
Study results publicly available
July 10, 2024
CompletedJuly 10, 2024
July 1, 2024
2.9 years
January 14, 2015
December 21, 2022
July 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization.
Progression was defined as radiological progression according to RECIST v1.1 criteria and/or clinical progression according to the investigator. Progression or death (for any reason) was considered if the event occured within the first 6 months since randomization. 6 month scans were 6 month scans with a +/- 1 month window.
6 months after randomization
Secondary Outcomes (2)
Overall Survival (OS)
Up to 3 years after the treatment start
Progression-free Survival (PFS)
up to 12 months after randomization
Study Arms (3)
FOLFIRINOX
ACTIVE COMPARATOREvery two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours
FOLFIRINOX + LV5FU2 in maintenance
EXPERIMENTALFolfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours.
FIRGEM
EXPERIMENTALAlternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest )
Interventions
Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue
Eligibility Criteria
You may qualify if:
- Metastatic disease
- At least one mesurable lesion according to RECIST V1.1 criteria
- No prior chemotherapy (excepted if there is at least on lestion out of the irradition area)
- Performance statut (WHO) 0-1
- Polynyclear ≥ 1500/mm3
- Bilirubine ≤ 1,5 fois la LSN, creatinin \< 120μmol / L
- Signed informed consent form
You may not qualify if:
- Another type of pancreas tumor, as endocrine tumor ou with acinous cells
- Ampulloma
- Cerebral or meningeal metastasis
- Gilbert disease
- Neuropathie \> or = grade 1
- Study treatments contraindication
- Uncontrolled diarrhoea or inflamatory disease of colon or rectum, or bowel obstruction or bowel sub-obstruction no resolved with specific treatment
- Significant previous cardiac and respiratory disease
- Patient included in an other therapeutic study with experimental treatment
- Pregnancy or breast feeding
- Patient depreved of freedom or under gardianship
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
CHU - Hôtel Dieu
Angers, France
CH
Auxerre, France
CH - Henri Duffaut
Avignon, France
Centre d'oncologie et de radiothérapie
Bayonne, France
CH
Bayonne, France
Ch - Ch Beauvais
Beauvais, France
CHU
Besançon, France
Bezier Ch
Béziers, 34525, France
Hôpital Avicenne
Bobigny, France
Polyclinique Bordeaux Nord
Bordeaux, France
CH -Duchenne
Boulogne-sur-Mer, France
CHU Côte de Nacre
Caen, France
CHU Estaing
Clermont-Ferrand, France
Hôpitaux Civils de Colmar
Colmar, France
CH Compiègne-Noyon
Compiègne, France
CHG
Corbeil-Essonnes, France
CHU - Hôpital François Mitterand
Dijon, France
CH
Dunkirk, France
CHU de Grenoble
Grenoble, France
Institut Daniel Hollard / Groupe Hospitalier Mutualiste
Grenoble, France
Clinique Sainte Marguerite
Hyères, France
CH Marne La Vallée Jossigny
Jossigny, France
CHD
La Roche-sur-Yon, France
CHU - Claude Huriez
Lille, France
Hôpital du Scorff
Lorient, France
CHU - Hôpital Edouard Herriot
Lyon, France
Clinique de la Sauvegarde
Lyon, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Privé Jean Mermoz
Lyon, France
La Timone
Marseille, 13000, France
Hôpital Européen de Marseille
Marseille, France
Hôpital privé
Marseille, France
CH - Centre Hospitalier de Meaux
Meaux, France
Centre Antoine Lassagne
Nice, France
Hôpital de la Source -service HGE et cancérologie digestive
Orléans, France
Hôpital de la Source- service d'oncologie
Orléans, France
CHU AP - HP - Hôpital Européen Georges Pompidou
Paris, France
Groupe Hospitalier Saint Joseph
Paris, France
Hôpital La Pitié Salpetière
Paris, France
CH Pau
Pau, France
Centre Hospitalier Annecy Genevois
Pringy, France
CHU Robert Debré
Reims, France
Centre Eugène Marquis
Rennes, France
CHU - Charles Nicolle
Rouen, France
CHU
Saint-Etienne, France
CH
Soissons, France
CH
St-Malo, France
Centre Paul Strauss
Strasbourg, France
Clinique Sainte Anne
Strasbourg, France
CH - Bigorra
Tarbes, France
Hôpityal Trousseau
Tours, France
CH
Valenciennes, France
Institut Gustave Roussy
Villejuif, France
Hôpital Privé de Villeneuve d'Ascq
Villeneuve-d'Ascq, France
Related Publications (2)
Dahan L, Williet N, Le Malicot K, Phelip JM, Desrame J, Bouche O, Petorin C, Malka D, Rebischung C, Aparicio T, Lecaille C, Rinaldi Y, Turpin A, Bignon AL, Bachet JB, Seitz JF, Lepage C, Francois E; PRODIGE 35 Investigators/Collaborators. Randomized Phase II Trial Evaluating Two Sequential Treatments in First Line of Metastatic Pancreatic Cancer: Results of the PANOPTIMOX-PRODIGE 35 Trial. J Clin Oncol. 2021 Oct 10;39(29):3242-3250. doi: 10.1200/JCO.20.03329. Epub 2021 Jul 21.
PMID: 34288696RESULTBoisteau E, Dahan L, Williet N, Le Malicot K, Desrame J, Bouche O, Petorin C, Malka D, Rebischung C, Aparicio T, Lecaille C, Rinaldi Y, Turpin A, Bignon AL, Bachet JB, Lepage C, Granger V, Legoux JL, Deplanque G, Baconnier M, Lecomte T, Bonnet I, Seitz JF, Francois E, Lievre A; PRODIGE 35 Investigator/Collaborators. Clinico-biological factors predicting the benefit of the LV5FU2 maintenance strategy as a first-line therapy in patients with metastatic pancreatic cancer. Oncologist. 2024 Sep 6;29(9):e1149-e1158. doi: 10.1093/oncolo/oyae079.
PMID: 39235326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karine Le Malicot
- Organization
- Fédération Francophone de Cancérologie Digestive
Study Officials
- PRINCIPAL INVESTIGATOR
DAHAN Laetitia, MD
MARSEILLE La Timone
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2015
First Posted
February 2, 2015
Study Start
January 12, 2015
Primary Completion
December 1, 2017
Study Completion
August 1, 2021
Last Updated
July 10, 2024
Results First Posted
July 10, 2024
Record last verified: 2024-07