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

Summary

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.

Interventions

• 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.

• MRI-guided adaptive stereotactic radiotherapy (SMART) · RADIATION

  MRI-guided adaptive stereotactic radiotherapy (SMART) 50 Gy / 5 fractions without concomitant chemotherapy.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (17)

• Centre d'Oncologie du Pays-Basque, Bayonne, France
• Institut Bergonié, Bordeaux, France
• CHU Brest, Brest, France
• Centre Hospitalier Carcassone, Carcassonne, France
• Centre Jean PERRIN, Clermont-Ferrand, France
• Centre Georges François Leclerc, Dijon, France
• Centre Oscar Lambret, Lille, France
• Institut Paoli-Calmettes, Marseille, France
• Institut régional du Cancer de Montpellier, Montpellier, France
• CHU Nîmes, Nîmes, France
• Hôpital européen Georges-Pompidou, Paris, France
• Hôpital Tenon AP-HP, Paris, France
• HU Pitié-Salpêtrière, Paris, France
• CHU Bordeaux Haut-Lévêque, Pessac, France
• Centre Eugène Marquis, Rennes, France
• Institut Claudius Regaud, Toulouse, France
• ORLAM, Villeurbanne, France