Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
NCT ID: NCT03943667
Last Updated: 2026-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
211 participants
INTERVENTIONAL
2019-05-23
2022-04-26
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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GEMPAX
Gemcitabine + Paclitaxel until progression
Gemcitabine
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel
80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
Control
Gemcitabine alone until progression
Gemcitabine
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Interventions
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Gemcitabine
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel
80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area
* Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
* Life expectancy ≥12 weeks
* Negative serology (HIV, hepatitis B and C)
* Adequate organs function
* Proven Post-menopausal status or negative urinary or serum pregnancy test
* Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment
* Patients affiliated to the social security system
* Patient must have signed a written informed consent form
Exclusion Criteria
* Known cerebral metastasis
* Uncontrolled severe infections
* Patients with Kaposi's sarcoma
* Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
* Previous treatment with taxane and/or gemcitabine (for pancreas cancer only)
* Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient
* Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment
* Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial
* Participation in another clinical trial within 14 days prior to randomization
* Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Christelle de la FOUCHARDIERE, Dr
Role: PRINCIPAL_INVESTIGATOR
UNICANCER
Locations
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CH de Bayeux
Bayeux, , France
CH Simone Veil
Beauvais, , France
CHU Jean Minjoz
Besançon, , France
Hôpital Duchenne
Boulogne-sur-Mer, , France
CH du Cotentin
Cherbourg, , France
Centre Georges François Leclerc
Dijon, , France
Centre Léon Bérard
Lyon, , France
Hospices civils de Lyon
Lyon, , France
CHU La Timone
Marseille, , France
Hôpital Européen de Marseille
Marseille, , France
Hôpital Saint-Joseph
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
Hôpital Nord Franche Comté
Montbéliard, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Saint-Louis
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hôpital Pitié-Salpétrière
Paris, , France
Institut Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
CHU Rouen
Rouen, , France
Institut Curie
Saint-Cloud, , France
CHU de Saint-Etienne
Saint-Etienne, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
Hôpital Broussais
St-Malo, , France
Hôpital Trousseau
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
De La Fouchardiere C, Malka D, Cropet C, Chabaud S, Raimbourg J, Botsen D, Launay S, Evesque L, Vienot A, Perrier H, Jary M, Rinaldi Y, Coutzac C, Bachet JB, Neuzillet C, Williet N, Desgrippes R, Grainville T, Aparicio T, Peytier A, Lecomte T, Roth GS, Thirot-Bidault A, Lachaux N, Bouche O, Ghiringhelli F. Gemcitabine and Paclitaxel Versus Gemcitabine Alone After 5-Fluorouracil, Oxaliplatin, and Irinotecan in Metastatic Pancreatic Adenocarcinoma: A Randomized Phase III PRODIGE 65-UCGI 36-GEMPAX UNICANCER Study. J Clin Oncol. 2024 Mar 20;42(9):1055-1066. doi: 10.1200/JCO.23.00795. Epub 2024 Jan 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002886-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PRODIGE 65 - UCGI 36
Identifier Type: OTHER
Identifier Source: secondary_id
UC-0110/1809
Identifier Type: -
Identifier Source: org_study_id
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