Last updated on December 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Cancer | Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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