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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 : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE August 3, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date September 12, 2019
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02539537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • 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.
  • Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy [ Time Frame: During treatment phase, 24 weeks ]
    Observance of chemotherapy
  • Overall Survival [ Time Frame: Until death, assessed up 128 weeks after randomization ]
  • Progression-free survival: pattern of failure [ Time Frame: Until Disease Progression, assessed uo until 128 weeks after randomization ]
  • Percentage of secondarily curative-intent surgery [ Time Frame: Until surgery, if applicable, up until 128 weeks after randomization ]
  • 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),
  • Time to treatment failure [ Time Frame: Until disease progression, assessed up until 128 weeks after randomization ]
  • Quality of life (QLQ C30) [ Time Frame: assessed up until 128 weeks after randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • 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.
  • Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy [ Time Frame: During treatment phase, 24 weeks ]
    Observance of chemotherapy
  • Overall Survival [ Time Frame: Until death, assessed up 128 weeks after randomization ]
  • Progression-free survival: pattern of failure [ Time Frame: Unitil Disease Progression, assessed uo until 128 weeks after randomization ]
  • Percentage of secondarily curative-intent surgery [ Time Frame: Until surgery, if applicable, up until 128 weeks after randomization ]
  • 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),
  • Time to treatment failure [ Time Frame: Until disease progression, assessed up until 128 weeks after randomization ]
  • Quality of life (QLQ C30) [ Time Frame: assessed up unitil 128 weeks after randomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
Official Title  ICMJE A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
Brief Summary French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Cancer
  • Carcinoma
Intervention  ICMJE
  • Drug: Gemcitabine
  • Drug: Folinic Acid
  • Drug: 5-Fluoro-uracil
  • Drug: Oxaliplatin
  • Drug: Irinotecan
  • Drug: L-folinic
Study Arms  ICMJE
  • 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).
    Intervention: 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-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).

    Interventions:
    • Drug: Folinic Acid
    • Drug: 5-Fluoro-uracil
    • Drug: Oxaliplatin
    • Drug: Irinotecan
    • Drug: L-folinic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2015)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laure MONARD +33 (0)1 73 79 73 09 l-monard@unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02539537
Other Study ID Numbers  ICMJE PRODIGE 29 (UCGI 26)
2014-003510-82 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel DUCREUX, Professor Gustave ROUSSY
PRS Account UNICANCER
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP