About this trial
Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female age > 18 years at time of study entry
Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
Patients with pancreatic adenocarcinoma
Patients with unresectable locally advanced pancreatic cancer or metastatic pancreatic cancer
Disqualifiers
Patient with neuroendocrine carcinoma or acinar cell carcinoma
Other cancer in the 5 years preceding inclusion or concomitant (except cancer in situ of the uterine cervix or cutaneous basal cell carcinoma).
Presence of brain metastasis(es)
Estimated prognosis < 3 months
Trial design
Single group
Treatments tested in this trial
FOLFIRINOX treatment
DrugTreatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival (PFS)
Progression-free survival (PFS) on FOLFIRINOX3 at 6 months.
Secondary outcomes
Overall survival (OS)
Overall survival (OS) is defined as the time interval between the date of inclusion and the date of death from any cause.
Acute and late toxicities (adverses events)
Acute toxicity is defined as toxicity occurring within 6 months of the start of chemotherapy. A toxicity is late if it occurs more than 6 months after the start of chemotherapy.
Quality of life (QoL)
Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the cancer-specific QLQ-C30
Quality of life (QoL)
Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the QLQPAN26,a module specific to pancreatic cancer.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.