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

  • STATUS
    Recruiting
  • End date
    Sep 2, 2024
  • participants needed
    170
  • sponsor
    UNICANCER
Updated on 2 April 2021
ct scan
carcinoma
metastasis
oxaliplatin
neutrophil count
pancreatic adenocarcinoma
gemcitabine
leucovorin
irinotecan
chemotherapy regimen
cancer chemotherapy
adenocarcinoma
celiac
folfirinox

Summary

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

Description

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

Details
Condition Pancreatic Cancer, Pancreatic Cancer, Islet Ce417ll Cancer, Pancreatic disorder, Pancreatic Disorders, Carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Pancreatic Disorders, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic, carcinomas
Treatment Gemcitabine, Irinotecan, Oxaliplatin, Folinic Acid, 5-Fluoro-uracil, L-folinic
Clinical Study IdentifierNCT02539537
SponsorUNICANCER
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed adenocarcinoma of the pancreas
Proven unresectability after multidisciplinary discussion involving radiologist and a surgeon
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)
Measurable tumor lesions with longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan according RECIST 1.1
WHO Performance status (PS) 0-1
Age 18 years
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
Adequate vital functions
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
Patient information and signed informed consent form
Public or private health insurance coverage
Uracilemia < 16 ng/ml

Exclusion Criteria

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
Patient with metastasis or with history of metastasis
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)
Major comorbidity, active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes that may preclude the delivery of the treatment
Pre-existing neuropathy (Grade 2), Gilbert's disease or genotype UGT1A1 28 / 28
Pregnant woman
Fructose intolerance
Patients currently treated by warfarin
Persons deprived of liberty or under guardianship
Psychological condition, family-, sociological- or geographical situation potentially hampering compliance with the study protocol and the follow-up schedule
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