The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer
Male or female aged 18 to 75 on the date the consent is signed.
Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data.
One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast).
Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected.
Known brain metastasis.
Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease.
Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment.
Known Gilbert's syndrome or homozygous for know UGT1A1 * 28
Parallel
GEMBRAX/FOLFIRINOX Arm A
Combination productPatients in the experimental arm received sequential treatment: A maximum of 6 cycles (12 months) of chemotherapy; One cycle = 3 administrations of GEMBRAX followed by 2 administrations of FOLFIRINOX
FOLFIRINOX Arm B
Combination productPatients in this arm received : A maximum of 3 cycles (6 months) of chemotherapy. One cycle = 4 administrations of FOLFIRINOX
Progression-free survival
To compare progression-free survival between the investigational treatment (Arm A) and the standard treatment (Arm B) in patients with metastatic 1st line pancreatic adenocarcinoma. Progression-free survival defined as the time between randomization and the onset of the 1st documented progression or death from any cause. Tumor progression is assessed according to the RECIST 1.1 criteria and by the centralized review.
Tolerability of treatments
Adverse events rate assessed according to the NCI-CTC AE V5.0 classification in application
Objective response rate
Objective response rate (best response during treatment) defined as the percentage of complete or partial response. The tumor response is evaluated according to the RECIST 1.1 criteria.
Disease control rate
Disease control rate defined as the percentage of complete or partial response or stability. The tumor response is evaluated according to the RECIST 1.1 criteria.
Overall survival
Overall survival defined as the time between randomization and the onset of death regardless of the cause.
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