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

NCT07097064 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PROICM 2024-06 RAI
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 17

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.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

Pancreatic Adenocarcinoma; adaptative radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 (9)

• Evaluation of Overall Survival

  1 year after enrollment

• Evaluation of progression-free survival

  1 year after enrollment

• Evaluation of Metastasis-free survival

  1 year after enrollment

• Evaluation of severe acute gastrointestinal toxicity

  90 days after the end of radiotherapy

• Evaluation of safety (acute and late toxicities of RT)

  Up to 5 years after treatment

Study Arms (2)

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

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.

Standard cohort

MRI-guided adaptive stereotactic radiotherapy (SMART) RADIATION

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

Experimental cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (17)

Centre d'Oncologie du Pays-Basque

Bayonne, 64100, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

CHU Brest

Brest, 29200, France

Location

Centre Hospitalier Carcassone

Carcassonne, 11010, France

Location

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

CHU Nîmes

Nîmes, 30029, France

Location

Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

Hôpital Tenon AP-HP

Paris, 75020, France

Location

HU Pitié-Salpêtrière

Paris, 75651, France

Location

CHU Bordeaux Haut-Lévêque

Pessac, 33604, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

ORLAM

Villeurbanne, 69100, France

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Aurore MOUSSION

CONTACT

+33467613102; drci-soumissions@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2033
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)