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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 : March 24, 2021
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

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

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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
Actual Study Start Date : March 23, 2015
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

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 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).

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 ]
    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.

  4. Progression-free survival: pattern of failure [ Time Frame: Until Disease Progression, assessed uo until 128 weeks after randomization ]
    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.

  5. Percentage of secondarily curative-intent surgery [ Time Frame: Until surgery, if applicable, up until 128 weeks after randomization ]
    Percentage of patients who will undergo an exeresis of their pancreatic tumor, with R0 resection confirmed by anatomopathic pathology.

  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: From randomisation to the end of treatment ]
    Time to treatment failure

  8. Quality of life questionnaire - Core 30 (QLQ-C30) [ Time Frame: assessed up until 128 weeks after randomization ]
    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.



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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
  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

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
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Contact: Nicolas DE SOUSA CARVALHO +33 (0)1 71 93 67 09 n-de-sousa@unicancer.fr

Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Michel DUCREUX, Professor Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02539537    
Other Study ID Numbers: PRODIGE 29 (UCGI 26)
2014-003510-82 ( EudraCT Number )
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Access Criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
locally advanced pancreatic carcinoma
FOLFIRINOX
Additional relevant MeSH terms:
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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
Leucovorin
Folic Acid
Gemcitabine
Fluorouracil
Oxaliplatin
Irinotecan
Levoleucovorin
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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors