A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
NCT ID: NCT02539537
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
171 participants
INTERVENTIONAL
2015-10-23
2023-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Gemcitabine
Gemcitabine 1000 mg/m² IV infusion over 30 minutes on D1 of each week for the 4 weeks of the first cycle (1 cycle = 4 weeks). For the following five cycles, gemcitabine infusion on D1, D8, and D15 of each cycle, followed by 1 week without injection (i.e. in total 4 cycles over 24 weeks; with 19 administrations of Gemcitabine).
Gemcitabine
Arm B: Folfirinox
Administered once every 14 days for 24 weeks (12 cycles). A cycle equals 14 days with injection on D1 of each cycle. Treatment starts with oxaliplatin (85 mg/m²) administration; IV infusion over 2 hours, followed by the simultaneous administration (using a Y-tubing) of folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours and irinotecan 180 mg/m² IV infusion over 90 minutes. The irinotecan will begin 30 minutes after the start of the folinic acid infusion.
5-Fluoro-uracil (5-FU) IV 2,400 mg/m²/h will be administered over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m²/day for the duration of 2 days.
Treatment will be continued for 24 weeks (12 cycles).
Folinic Acid
5-Fluoro-uracil
Oxaliplatin
Irinotecan
L-folinic
Interventions
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Gemcitabine
Folinic Acid
5-Fluoro-uracil
Oxaliplatin
Irinotecan
L-folinic
Eligibility Criteria
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Inclusion Criteria
2. Proven unresectability after multidisciplinary discussion involving radiologist and a surgeon
3. Locally advanced (i.e.: no metastasis or suspicion of metastasis) and unresectable tumors: for example mesenteric or portal vein involvement, or \> 180° encasement of the superior mesenteric artery, or celiac abutment (NCCN 2012 criteria)
4. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST 1.1
5. WHO Performance status (PS) 0-1
6. Age ≥18 years
7. Patient with organ function as follows:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
* Hemoglobin ≥ 10 g/dL
* Platelets (PTL) ≥ 75 x 10⁹/L
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
* Bilirubin ≤ 1.5 x ULN
* Creatinine ≤ 2 x ULN
* Albumin \> 0.75 x lower limit of normal (LLN)
* Urea ≤ 2 x ULN
8. Adequate vital functions
9. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use medically acceptable methods of contraception during the study and for 4 months after the last intake of study treatment for women and for 6 months after for men.
10. Patient information and signed informed consent form
11. Public or private health insurance coverage
12. Uracilemia \< 16 ng/ml
Exclusion Criteria
2. Patient with metastasis or with history of metastasis
3. Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline)
4. Major comorbidity, active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes that may preclude the delivery of the treatment
5. Pre-existing neuropathy (Grade ≥ 2), Gilbert's disease or genotype UGT1A1 \* 28 / \* 28
6. Pregnant woman
7. Fructose intolerance
8. Patients currently treated by warfarin
9. Persons deprived of liberty or under guardianship
10. Psychological condition, family-, sociological- or geographical situation potentially hampering compliance with the study protocol and the follow-up schedule
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Michel DUCREUX, Professor
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, , France
CHU Amiens - Hôpital Nord
Amiens, , France
CHU d'Angers
Angers, , France
Centre hospitalier d'Auxerre
Auxerre, , France
Centre hospitalier Henri Duffaut
Avignon, , France
Hôpital Avicenne
Bobigny, , France
Institut Bergonié
Bordeaux, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
CH Boulogne sur Mer
Boulogne-sur-Mer, , France
CHU Côte de Nacre
Caen, , France
Centre François Baclesse
Caen, , France
Hôpital Trousseau
Chambray-lès-Tours, , France
Hôpitaux civils de Colmar
Colmar, , France
CH de Dijon
Dijon, , France
CHD Vendée
La Roche-sur-Yon, , France
Centre Hospitalier de Laon
Laon, , France
Centre Oscar Lambret
Lille, , France
CHU de Limoges
Limoges, , France
Hôpital Edouard Herriot - Lyon
Lyon, , France
Hôpital Saint Joseph Saint Luc
Lyon, , France
Hôptal Européen
Marseille, , France
Hôpital De La Timone
Marseille, , France
Centre Hospitalier de Meaux
Meaux, , France
Groupe Hospitalier du Havre Jacques Monod
Montivilliers, , France
CHU Hotel Dieu
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CHR d'Orléans La Source
Orléans, , France
Hôpital Saint Antoine
Paris, , France
Groupe hospitalier Paris Saint Joseph
Paris, , France
Groupe hospitalier Pitié Salpétrière
Paris, , France
CH Annecy Genevois
Pringy, , France
CHU - Robert Debre
Reims, , France
CHU Rouen
Rouen, , France
CHI Elbeuf
Saint-Aubin-lès-Elbeuf, , France
Hôpital Privé des Côtes d'Armor
Saint-Brieuc, , France
Centre Regional René Gauducheau
Saint-Herblain, , France
Clinique mutualiste de l'Estuaire
Saint-Nazaire, , France
Institut de cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Hôpital privé Saint Claude
Saint-Quentin, , France
Centre Hospitalier de Soissons
Soissons, , France
Centre Hospitalier de Saint Malo
St-Malo, , France
Centre Paul Strass
Strasbourg, , France
Polyclinique de l'Ormeau-GROP
Tarbes, , France
Centre Hospitalier de Rangueil
Toulouse, , France
Gustave Roussy
Villejuif, , France
Countries
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References
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Ducreux M, Desgrippes R, Rinaldi Y, Di Fiore F, Guimbaud R, Evesque L, Bachet JB, Vanelslander P, Lecomte T, Capitain O, Parzy A, Bolliet M, Etienne PL, Forestier J, El Hajbi F, Bignon AL, Lebrun-Ly V, De Sousa Carvalho N, Texier M, Bouche O. PRODIGE 29-UCGI 26 (NEOPAN): A Phase III Randomized Trial Comparing Chemotherapy With FOLFIRINOX or Gemcitabine in Locally Advanced Pancreatic Carcinoma. J Clin Oncol. 2025 Jul 10;43(20):2255-2264. doi: 10.1200/JCO-24-02210. Epub 2025 May 16.
Other Identifiers
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2014-003510-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PRODIGE 29 (UCGI 26)
Identifier Type: -
Identifier Source: org_study_id
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