Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.
Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer. Treatment 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Treatment 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
Centre Georges-François Leclerc
Dijon, France
RECRUITINGProgression-free survival (PFS)
Progression-free survival (PFS) on FOLFIRINOX3 at 6 months.
Time frame: 6 months
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.
Time frame: 24 months
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.
Time frame: Until 30 days after the end of treatment
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
Time frame: Until the end of treatment an average of 14 months
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.
Time frame: Until the end of treatment an average of 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.