A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

Pancreatic Cancer Clinical Trial

— NEOPAN  

Official title:

A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539537
• Other study ID #: PRODIGE 29 (UCGI 26)
• Secondary ID: 2014-003510-82
• Status: Completed
• Phase: Phase 3
• Start date: October 23, 2015
• Est. completion date: September 25, 2023

Study information

• Verified date: January 2024
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.

Description:

Comparative interventional prospective phase 3, randomized, open-label, multicentric trial comparing chemotherapy with Folfirinox to Gemcitabine in locally advanced pancreatic carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: September 25, 2023
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas

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 10?/L

• Hemoglobin = 10 g/dL

• Platelets (PTL) = 75 x 10?/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:

1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or in situ cervical cancer

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

Related Conditions & MeSH terms

• Carcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine

• Folinic Acid

• 5-Fluoro-uracil

• Oxaliplatin

• Irinotecan

• L-folinic

Locations

Country	Name	City	State
France	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	Centre François Baclesse	Caen
France	CHU Côte de Nacre	Caen
France	Hôpital Trousseau	Chambray-les-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	Hôpital De La Timone	Marseille
France	Hôptal Européen	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	Groupe hospitalier Paris Saint Joseph	Paris
France	Groupe hospitalier Pitié Salpétrière	Paris
France	Hôpital Saint Antoine	Paris
France	CH Annecy Genevois	Pringy
France	CHU - Robert Debre	Reims
France	CHU Rouen	Rouen
France	Hôpital Privé des Côtes d'Armor	Saint Brieuc
France	Centre Regional René Gauducheau	Saint Herblain
France	Centre Hospitalier de Saint Malo	Saint Malo
France	Institut de cancérologie Lucien Neuwirth	Saint Priest En Jarez
France	CHI Elbeuf	Saint-Aubin-lès-Elbeuf
France	Clinique mutualiste de l'Estuaire	Saint-Nazaire
France	Hôpital privé Saint Claude	Saint-quentin
France	Centre Hospitalier de Soissons	Soissons
France	Centre Paul Strass	Strasbourg
France	Polyclinique de l'Ormeau-GROP	Tarbes
France	Centre Hospitalier de Rangueil	Toulouse
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival (PFS)	To compare Progression-Free-Survival (PFS) between the two treatment arms	From randomization until disease progression or date of death, assessed up until to 128 weeks
Secondary	Composite index for treatment early severe toxicity	Biliary tract infection Grade 3-4 + any grade 5 toxicities + chemotherapy interruption for toxicity during the first four cycles.	First four chemotherapy cycles, 16 weeks
Secondary	Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy	Observance of chemotherapy	During treatment phase, 24 weeks
Secondary	Overall Survival	The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.	Until death, assessed up 128 weeks after randomization
Secondary	Progression-free survival: pattern of failure	The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.	Until Disease Progression, assessed uo until 128 weeks after randomization
Secondary	Percentage of secondarily curative-intent surgery	Percentage of patients who will undergo an exeresis of their pancreatic tumor, with R0 resection confirmed by anatomopathic pathology.	Until surgery, if applicable, up until 128 weeks after randomization
Secondary	Objective tumour response, disease control and their duration	Objective tumour response, disease control and their duration (RECIST version 1.1),	Until disease progression or date of death, assessed up until 128 weeks after randomization
Secondary	Time to treatment failure	Time to treatment failure	From randomisation to the end of treatment
Secondary	Quality of life questionnaire - Core 30 (QLQ-C30)	Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	assessed up until 128 weeks after randomization