NCT07097064

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	standard radiotherapy with chemotherapy	intensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5d/7.
RADIATION	MRI-guided adaptive stereotactic radiotherapy (SMART)	MRI-guided adaptive stereotactic radiotherapy (SMART) 50 Gy / 5 fractions without concomitant chemotherapy.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-01
• Completion: 2033-09-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

17 sites across 1 country: France