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Trial record 1 of 1 for:    NEOPAN
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A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma (NEOPAN)

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ClinicalTrials.gov Identifier: NCT02539537
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
UNICANCER

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Carcinoma Drug: Gemcitabine Drug: Folinic Acid Drug: 5-Fluoro-uracil Drug: Oxaliplatin Drug: Irinotecan Drug: L-folinic Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
Study Start Date : March 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
Drug: Gemcitabine
Experimental: 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 min. The irinotecan will begin 30 min. after the start of the folinic acid infusion.

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).

Drug: Folinic Acid
Drug: 5-Fluoro-uracil
Drug: Oxaliplatin
Drug: Irinotecan
Drug: L-folinic



Primary Outcome Measures :
  1. Progression-Free-Survival (PFS) [ Time Frame: From randomization until disease progression or date of death, assessed up until to 128 weeks ]
    To compare Progression-Free-Survival (PFS) between the two treatment arms


Secondary Outcome Measures :
  1. Composite index for treatment early severe toxicity [ Time Frame: First four chemotherapy cycles, 16 weeks ]
    Biliary tract infection Grade 3-4 + any grade 5 toxicities + chemotherapy interruption for toxicity during the first four cycles.

  2. Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy [ Time Frame: During treatment phase, 24 weeks ]
    Observance of chemotherapy

  3. Overall Survival [ Time Frame: Until death, assessed up 128 weeks after randomization ]
  4. Progression-free survival: pattern of failure [ Time Frame: Until Disease Progression, assessed uo until 128 weeks after randomization ]
  5. Percentage of secondarily curative-intent surgery [ Time Frame: Until surgery, if applicable, up until 128 weeks after randomization ]
  6. Objective tumour response, disease control and their duration [ Time Frame: Until disease progression or date of death, assessed up until 128 weeks after randomization ]
    Objective tumour response, disease control and their duration (RECIST version 1.1),

  7. Time to treatment failure [ Time Frame: Until disease progression, assessed up until 128 weeks after randomization ]
  8. Quality of life (QLQ C30) [ Time Frame: assessed up until 128 weeks after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 criteria
  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
    • AST/ALT ≤ 2.5x ULN
    • bilirubin ≤ 1.5 x ULN
    • creatinine ≤ 2 x ULN
    • albumin > 0.75 x 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

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 warfarine
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539537


Contacts
Contact: Laure MONARD +33 (0)1 73 79 73 09 l-monard@unicancer.fr

Locations
France
CHU Amiens - Hôpital Nord Recruiting
Amiens, France
Principal Investigator: Vincent HAUTEFEUILLE, Dr         
Institut de cancérologie de l'Ouest - Site Paul Papin Active, not recruiting
Angers, France, 49933
Centre hospitalier d'Auxerre Recruiting
Auxerre, France
Contact: Anne-Laure VILLING, Dr         
Centre hospitalier Henri Duffaut Recruiting
Avignon, France
Contact: Thibault BROTELLE, Dr         
Hôpital Avicenne Active, not recruiting
Bobigny, France, 93000
Institut Bergonié Active, not recruiting
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Active, not recruiting
Bordeaux, France, 33077
CH Boulogne sur Mer Active, not recruiting
Boulogne sur Mer, France, 62321
CHU Côte de Nacre Active, not recruiting
Caen, France, 14033
Centre François Baclesse Active, not recruiting
Caen, France, 14076
Hôpital Trousseau Recruiting
Chambray-les-tours, France
Principal Investigator: Thierry LECOMTE, Dr         
Hôpitaux civils de Colmar Recruiting
Colmar, France
Contact: Gilles BREYSACHER, Dr         
CHD Vendée Active, not recruiting
La Roche Sur Yon, France, 85925
Centre Hospitalier de Laon Active, not recruiting
Laon, France, 02000
Centre Oscar Lambret Recruiting
Lille, France, 59020
Principal Investigator: Antoine ADENIS, Pr         
Hôpital Privé Jean Mermoz Active, not recruiting
Lyon, France, 69008
Hôpital Edouard Herriot - Lyon Recruiting
Lyon, France, 69437
Principal Investigator: Julien FORESTIER, Dr         
Hôptal Européen Active, not recruiting
Marseille, France, 13003
Hôpital De La Timone Active, not recruiting
Marseille, France, 13365
Centre Hospitalier de Meaux Active, not recruiting
Meaux, France, 77000
CHU Hotel Dieu Recruiting
Nantes, France
Contact: Yann TOUCHEFEU, Dr         
Centre Antoine Lacassagne Recruiting
Nice, France
Principal Investigator: Philippe FOLLANA, Dr         
Hôpital Saint Antoine Active, not recruiting
Paris, France, 75571
Groupe hospitalier Paris Saint Joseph Recruiting
Paris, France
Principal Investigator: Nabil BABA HAMED, Dr         
Groupe hospitalier Pitié Salpétrière Recruiting
Paris, France
Contact: Jean-Baptiste BACHET, Dr         
CHU - Robert Debre Recruiting
Reims, France, 51092
Principal Investigator: Olivier BOUCHE, Dr         
CHU Rouen Recruiting
Rouen, France
Principal Investigator: Frédéric DI FIORE, Dr         
Hôpital Privé des Côtes d'Armor Active, not recruiting
Saint Brieuc, France, 22190
Centre Regional René Gauducheau Recruiting
Saint Herblain, France
Principal Investigator: Olivier CAPITAIN, Dr         
Centre Hospitalier de Saint Malo Active, not recruiting
Saint Malo, France, 35403
Institut de cancérologie Lucien Neuwirth Active, not recruiting
Saint Priest En Jarez, France, 42271
Clinique mutualiste de l'Estuaire Recruiting
Saint-Nazaire, France
Principal Investigator: Catherine LIGEZA, Dr         
Hôpital privé Saint Claude Recruiting
Saint-quentin, France
Principal Investigator: Pierre VANELSLANDER, Dr         
Centre Hospitalier de Soissons Recruiting
Soissons, France, 02209
Principal Investigator: Sarah MONTEMBAULT, Dr         
Centre Hospitalier de Rangueil Recruiting
Toulouse, France, 31059
Principal Investigator: Rosine GUIMBAUD, Pr         
Institut de Cancérologie de Lorraine Active, not recruiting
Vandoeuvre Les Nancy, France, 54519
Gustave Roussy Recruiting
Villejuif, France
Principal Investigator: Michel DUCREUX, Pr         
Sponsors and Collaborators
UNICANCER

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02539537     History of Changes
Other Study ID Numbers: PRODIGE 29 (UCGI 26)
2014-003510-82 ( EudraCT Number )
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Keywords provided by UNICANCER:
locally advanced pancreatic carcinoma
FOLFIRINOX

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Irinotecan
Oxaliplatin
Leucovorin
Levoleucovorin
Folic Acid
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors