Pancreatic cancer is on the rise, and is set to become the 2nd leading cause of cancer deaths by 2030. Its prognosis is very poor, with a 5-year survival rate of just 5.5%. Curative surgery with chemotherapy improves survival, but only 20% of patients are eligible. For locally advanced forms, radiotherapy, notably in the form of MRI-guided adaptive stereotactic radiotherapy (SMART), is showing promising results in terms of survival and local control, but still requires prospective validation.
Histologically proven pancreatic adenocarcinoma ;
Age ≥ 18 years ;
WHO score 0-1 ;
Locally advanced according to NCCN 1.2015 recommendations;
Other concomitant cancer or history of cancer, with the exception of treated cervical cancer in situ, basal or squamous cell skin carcinoma, superficial bladder tumour (Ta, Tis, and T1) or a tumour with a good prognosis treated curatively without chemotherapy and without evidence of disease in the 3 years prior to inclusion ;
History of radiotherapy with a foreseeable overlap with the radiotherapy treatment under study (history of abdominal irradiation) ;
Contraindication to MRI and MRI-guided radiotherapy (claustrophobia, presence of metallic elements etc...) ;
History of chronic inflammatory disease of the colon or rectum ;
Parallel
standard radiotherapy with chemotherapy
Combination productintensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5d/7.
MRI-guided adaptive stereotactic radiotherapy (SMART)
RadiationMRI-guided adaptive stereotactic radiotherapy (SMART) 50 Gy / 5 fractions without concomitant chemotherapy.
Improvement of local control at 1 year by 20% in the experimental cohort compared with the standard cohort.
Local control rate, assessed by TAP scan according to RECIST 1.1 criteria (Appendix 8) +/- oesogastroduodenal fibroscopy (FOGD) in case of upper digestive symptomatology not explained by CT scan. The local control rate is defined as the proportion of patients without local progression, the time to local progression being defined as the time between the start date of radiotherapy and the date of documented local progression. Patients will be censored at date of death if they die of a carcinological outcome other than local recurrence, or of another cause. Patients without local progression will be censored at the date of last follow-up.
Evaluation of Overall Survival
Overall survival (OS) at 1 year, with overall survival defined as the time between the date of starting RT treatment and the date of death from any cause ;
Evaluation of progression-free survival
Progression-free survival (PFS) at 1 year, progression-free survival defined as the time between the date of starting RT treatment and the date of 1st documented progression or the date of death from any cause ; Progression will be assessed by TAP, or OGD if suspicion of local recurrence not identified on the scanner (same imaging technique for all patients) ;
Evaluation of Metastasis-free survival
Metastasis-free survival (MFS) at 1 year, with MFS defined as the time from the start date of RT treatment to the date of first metastatic progression; Metastatic progression will be assessed using CT-scan
Evaluation of severe acute gastrointestinal toxicity
Rate of intestinal and gastric toxicity grade \> 2 during and in the 90 days following the end of radiotherapy, evaluated according to the CTCAE v5.0 classification
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