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.
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.
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).
Single group
Gabrinox
Combination productRegimen: GEMBRAX Other Names: Albumin bound paclitaxel 125 mg/m² + Gemcitabine 1000 mg/m² Regimen: FOLFIRINOX Other Names: Oxaliplatin 85 mg/m² + Leucovorin 200 mg/m² + Irinotecan 180 mg/m² + 5FU bolus 400mg/m² + 5FU continuous 2400 mg/m² Gembrax + Folfirinox = GABRINOX
MRI-GUIDED STEREOTACTIC RADIOTHERAPY
RadiationRadiotherapy will start between 5 and 6 weeks after the last injection of chemotherapy (FOLFIRINOX regimen) in non-progressive patients after Gabrinox. Stereotactic adaptive radiotherapy in five fractions: prescription dose in five fractions of 10 Gy/day on consecutive days. At least two sessions/week should be performed. An interval of at least 18 hours between fractions is recommended.
Rate of non-progression at 4 months
(Sequence 1 success = chemotherapy) according to the RECIST v1.1 criteria
Acute gastrointestinal non-toxicity rate
Absence of toxicity of grade ≥3 related to radiotherapy within 90 days, evaluated using the NCI-CTCAE v5.0 classification (sequence 2 success = radiotherapy)
Assessment of adverse events due to chemotherapy by using the NCI-CTCAE version 5.0 scale
Adverse events of chemotherapy evaluated using the NCI-CTCAE v5.0 classification
Assessment of adverse events due to radiotherapy by using the NCI-CTCAE version 5.0
Adverse events of radiotherapy evaluated using the NCI-CTCAE v5.0 classification
Collection of dosimetric results regarding dose/volume from the planned dosimetry, such as coverage of the planning targeted volume (PTV) by the prescription dose in the accumulated dose
End of radiotherapy
Collection of dosimetric results regarding dose/volume from the planned dosimetry, such as dose received by the gross total volume
End of radiotherapy
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