Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GEMBRAX/FOLFIRINOX Arm A
  • FOLFIRINOX Arm B

Treatment groups

162 Participants
are divided into 2 treatment groups