• Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer

  NCT03621644

  Active, not recruitingInterventionalNot ApplicableUpdated Oct 14, 2022
• Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy

  NCT05585554

  Not yet recruitingInterventionalNot ApplicableUpdated Oct 19, 2022
• Stereotactic Magnetic Resonance Guided Radiation Therapy

  NCT04115254

  RecruitingInterventionalNot ApplicableUpdated Nov 13, 2025
• Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors

  NCT05609331

  TerminatedInterventionalNot ApplicableUpdated Nov 10, 2025
• Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma

  NCT04909294

  Active, not recruitingInterventionalNot ApplicableUpdated Feb 13, 2024
• Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma

  NCT06691425

  RecruitingInterventionalNot ApplicableUpdated Aug 8, 2025

ClinicalTrials.gov ID

NCT07097064

Lead Sponsor

Institut du Cancer de Montpellier - Val d'AurelleOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

160Estimated

Last Update Posted

Jul 31, 2025Actual

Start Date

Sep 2025Estimated

Primary Completion Date

Sep 2028Estimated

Completion Date

Sep 2033Estimated

Official Title

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

Brief 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.

Detailed Description

In 2016, pancreatic cancer became the 3rd leading cause of cancer death worldwide, and could be the 2nd by 2030. Its prognosis remains very unfavorable, with a 5-year overall survival rate of 5.5%, all stages combined. In France, incidence is on the rise, with 14,100 new cases and 11,400 deaths in 2018. The only therapeutic strategy that has shown a significant improvement in survival is curative surgery followed by adjuvant chemotherapy, but only 20% of patients are eligible. The majority of cases are diagnosed at an advanced or unresectable stage.

For locally advanced cancers (LACC), management is not standardized. Two induction chemotherapy regimens have been validated: FOLFIRINOX and GEMBRAX. The role of radiochemotherapy remains debated. The LAP07 study showed no significant benefit of radiochemotherapy on overall survival, although it did improve progression-free survival and locoregional control.

New techniques such as MRI-guided adaptive stereotactic radiotherapy (SMART) enable more targeted and intense delivery of radiation dose, while protecting organs at risk. Retrospective studies have shown a significant improvement in local control (up to 98% at 1 year) and overall survival (up to 23 months) with this method, compared with conventional radiotherapy. However, prospective studies are still needed to confirm the value of SMART in the management of locally advanced pancreatic cancer.

• Locally Advanced Pancreatic Adenocarcinoma

• standard radiotherapy with chemotherapy
• MRI-guided adaptive stereotactic radiotherapy (SMART)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Institut du Cancer de Montpellier - Val d'AurelleOTHER

p.sargos@bordeaux.unicancer.fr

vincent.bourbonne@chu-brest.fr

samir.hacene@ch-carcassonne.fr

genevieve.loos@clermont.unicancer.fr

mrouffiac@cgfl.fr

d-pasquier@o-lambret.fr

talleta@ipc.unicancer.fr

david.azria@chu-nimes.fr

jebibault@gmail.com

florence.huguet@aphp.fr

jean-marc.simon@aphp.fr

veronique.vendrely@chu-bordeaux.fr

i.masson@rennes.unicancer.fr

Keller.audrey@iuct-oncopole.fr

victor.passerat@gmail.com