First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem
Status:
Active, not recruiting
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is
note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease
with the survival median of 2-4 months without chemotherapy.
Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until,
the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with
gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months
with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities
of this treatment are hematological, gastrointestinal and neuropathy with apparition of
sensitive neuropathy, reversible, related to oxaliplatin.
These results are on a population under 76 years old. In this study, the median age of
patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more
than 65 years old. Given the increase of proportion of patients than more of 65 years old
with pancreatic cancer and given the increase of life expected, it is important to know the
effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.
FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4
cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance
known between this 2 treatments witch limit toxicities and preserve quality of life of
patients. A Phase II trial testing this treatment regimen to classical regimen of
gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall
survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of
progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this
strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of
treatment.
The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8
cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without
decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference
regimen.