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

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Updated on 2 April 2021

See if I qualify

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 Identifier	NCT02539537
Sponsor	UNICANCER
Last Modified on	2 April 2021

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