Evaluation of the Stereotactic MR-guided Adaptive Radiotherapy for Locally Advanced Pancreatic Cancers

Korábbi kezelés

• Contraindication to MRI and MRI-guided radiotherapy (claustrophobia, presence of metallic elements etc...) ;
• 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) ;
• Recent or concomitant treatment with brivudine.

Más betegség

• 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) ;
• History of chronic inflammatory disease of the colon or rectum ;
• History of severe and unexpected reactions to treatment containing a fluoropyrimidine ;
• Hypersensitivity to capecitabine, to used excipients or to fluorouracil ;
• In patients with severe hepatic insufficiency ;

Laborértékek

• Patients with severe renal insufficiency (creatinine clearance less than 30 mL/min) ;

Egyéb

• Women who are pregnant, parturient or breastfeeding ;
• Legal incapacity (patient under curatorship or guardianship) ;
• Known complete deficiency of dihydropyrimidine dehydrogenase (DPD) ;
• In patients with severe leukopenia, neutropenia or thrombocytopenia ;

• 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.