Evaluation of the Stereotactic MR-guided Adaptive Radioth... | NCT07097064

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard cohort	Active Comparator	intensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5 days a week (standard of care according to RECORAD and TNCD).	Combination Product: standard radiotherapy with chemotherapy
Experimental cohort	Experimental	MRI-guided adaptive stereotactic radiotherapy (extreme hypofractionation) (SMART) 50Gy/ 5 fractions without concomitant chemotherapy.	Radiation: MRI-guided adaptive stereotactic radiotherapy (SMART)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard radiotherapy with chemotherapy	Combination Product	intensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5d/7.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From enrollment to one year after treatment completion

Secondary Outcomes

Measure	Description	Time Frame
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 ;	1 year after enrollment
Evaluation of progression-free survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven pancreatic adenocarcinoma ;
Age ≥ 18 years ;
WHO score 0-1 ;
Locally advanced according to NCCN 1.2015 recommendations;
Non-metastatic after TAP scan and MRI of the liver ;
CA 19.9 < 1000 IU/mL ;
Completion of at least 4 cycles of induction chemotherapy (Folfirinox and/or Gemzar-Abraxane) with a maximum of 8 courses ;
Women of childbearing potential must have a pregnancy blood test within a maximum of 7 days before starting the study treatment. A negative result must be documented before study treatment is started. Women without reproductive potential are postmenopausal women or women who have undergone permanent sterilisation (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) ;
Effective contraception for women of childbearing age ;
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures ;
Patient has given informed, written and express consent ;
Patient affiliated to a French health insurance scheme.

Exclusion Criteria:

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 ;
Women who are pregnant, parturient or breastfeeding ;
Any other serious concomitant and unbalanced disease or disorder that may interfere with the patient's participation in the study and his/her safety during the study (e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders) ;
Legal incapacity (patient under curatorship or guardianship) ;
History of severe and unexpected reactions to treatment containing a fluoropyrimidine ;
Hypersensitivity to capecitabine, to used excipients or to fluorouracil ;
Known complete deficiency of dihydropyrimidine dehydrogenase (DPD) ;
In patients with severe leukopenia, neutropenia or thrombocytopenia ;
In patients with severe hepatic insufficiency ;
Patients with severe renal insufficiency (creatinine clearance less than 30 mL/min) ;
Recent or concomitant treatment with brivudine.