Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

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 demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.

The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.

Eligibility criteria

Qualifiers

Patient aged from 18 to 75 years at the date of signature of the consent form

Histologically or cytologically proven pancreatic adenocarcinoma

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Non-resectable tumour according to the National Comprehensive Cancer Network (NCCN) 1.2015 recommendations after external review of imaging data by multidisciplinary experts.

Disqualifiers

Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)

Gilbert's syndrome or homozygous Uridine DiPhosphate Glucuronosyl Transferase 1 A1 (UGT1A1 * 28)

Other concomitant cancer or history of cancer, except for treated in situ cancer of the cervix , basal cell or squamous cell carcinoma, superficial bladder tumour (Ta, Tis, and T1), or good-prognosis tumour cured without chemotherapy and without signs of disease in the 3 years before inclusion

Prior radiotherapy likely to overlap with the planned study radiotherapy area (e.g. previous abdominal irradiation).

Trial design

Treatments tested in this trial

  • Gabrinox
  • MRI-GUIDED STEREOTACTIC RADIOTHERAPY

Treatment groups

103 Participants
are divided into 1 treatment group