Carcinoma, Pancreatic Cancer
Conditions
Keywords
locally advanced pancreatic carcinoma, FOLFIRINOX
Brief summary
French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.
Detailed description
Comparative interventional prospective phase 3, randomized, open-label, multicentric trial comparing chemotherapy with Folfirinox to Gemcitabine in locally advanced pancreatic carcinoma.
Interventions
Sponsors
UNICANCER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival (PFS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy | During treatment phase, 24 weeks | Observance of chemotherapy |
| Overall Survival | Until death, assessed up 128 weeks after randomization | The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care. |
| Progression-free survival: pattern of failure | Until Disease Progression, assessed uo until 128 weeks after randomization | The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. |
| Composite index for treatment early severe toxicity | 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. |
| Objective tumour response, disease control and their duration | 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 | From randomisation to the end of treatment | Time to treatment failure |
| Quality of life questionnaire - Core 30 (QLQ-C30) | assessed up until 128 weeks after randomization | Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Percentage of secondarily curative-intent surgery | Until surgery, if applicable, up until 128 weeks after randomization | Percentage of patients who will undergo an exeresis of their pancreatic tumor, with R0 resection confirmed by anatomopathic pathology. |
Countries
France
Outcome results
None listed