Clinical trial NCT02539537: A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
Official title: A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Carcinoma
Keywords: locally advanced pancreatic carcinoma
FOLFIRINOX
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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 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:

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

Primary outcomes:
measure: Progression-Free-Survival (PFS)
timeFrame: From randomization until disease progression or date of death, assessed up until to 128 weeks
Secondary outcomes:
measure: Composite index for treatment early severe toxicity
timeFrame: First four chemotherapy cycles, 16 weeks
measure: Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy
timeFrame: During treatment phase, 24 weeks
measure: Overall Survival
timeFrame: Until death, assessed up 128 weeks after randomization
measure: Progression-free survival: pattern of failure
timeFrame: Until Disease Progression, assessed uo until 128 weeks after randomization
measure: Percentage of secondarily curative-intent surgery
timeFrame: Until surgery, if applicable, up until 128 weeks after randomization
measure: Objective tumour response, disease control and their duration
timeFrame: Until disease progression or date of death, assessed up until 128 weeks after randomization
measure: Time to treatment failure
timeFrame: From randomisation to the end of treatment
measure: Quality of life questionnaire - Core 30 (QLQ-C30)
timeFrame: assessed up until 128 weeks after randomization
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier Intercommunal Aix-Pertuis
city: Amiens
country: France
facility: CHU Amiens - Hôpital Nord
city: Angers
country: France
facility: CHU d'Angers
city: Auxerre
country: France
facility: Centre hospitalier d'Auxerre
city: Avignon
country: France
facility: Centre hospitalier Henri Duffaut
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Boulogne sur Mer
country: France
facility: CH Boulogne sur Mer
city: Caen
country: France
facility: CHU Côte de Nacre
city: Caen
country: France
facility: Centre François Baclesse
city: Chambray-les-tours
country: France
facility: Hôpital Trousseau
city: Colmar
country: France
facility: Hôpitaux civils de Colmar
city: Dijon
country: France
facility: CH de Dijon
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Laon
country: France
facility: Centre Hospitalier de Laon
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Lyon
city: Lyon
country: France
facility: Hôpital Saint Joseph Saint Luc
city: Marseille
country: France
facility: Hôptal Européen
city: Marseille
country: France
facility: Hôpital De La Timone
city: Meaux
country: France
facility: Centre Hospitalier de Meaux
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre Jacques Monod
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Orléans
country: France
facility: CHR d'Orléans La Source
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Groupe hospitalier Paris Saint Joseph
city: Paris
country: France
facility: Groupe hospitalier Pitié Salpétrière
city: Pringy
country: France
facility: CH Annecy Genevois
city: Reims
country: France
facility: CHU - Robert Debre
city: Rouen
country: France
facility: CHU Rouen
city: Saint Brieuc
country: France
facility: Hôpital Privé des Côtes d'Armor
city: Saint Herblain
country: France
facility: Centre Regional René Gauducheau
city: Saint Malo
country: France
facility: Centre Hospitalier de Saint Malo
city: Saint Priest En Jarez
country: France
facility: Institut de cancérologie Lucien Neuwirth
city: Saint-Aubin-lès-Elbeuf
country: France
facility: CHI Elbeuf
city: Saint-Nazaire
country: France
facility: Clinique mutualiste de l'Estuaire
city: Saint-quentin
country: France
facility: Hôpital privé Saint Claude
city: Soissons
country: France
facility: Centre Hospitalier de Soissons
city: Strasbourg
country: France
facility: Centre Paul Strass
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau-GROP
city: Toulouse
country: France
facility: Centre Hospitalier de Rangueil
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Michel DUCREUX, Professor
role: PRINCIPAL_INVESTIGATOR
References: