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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Fluorouracil; Folic Acid; Gemcitabine; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

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