NCT06024824

Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)

DP-IMRT Pancreas: A Non-randomised Phase I/II Study of Dose-escalated Hypofractionated Dose-Painted Intensity Modulated Radiotherapy (DPIMRT) in Resectable/Borderline Resectable Pancreatic Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective non-randomised Phase I/II Radiotherapy (RT) study with patients recruited to escalated dose cohorts. Patients with resectable or borderline resectable (per the National Comprehensive Cancer Network (NCCN) criteria) pancreatic adenocarcinoma will receive dose-escalated hypofractionated DP-IMRT via Intensity Modulated Radiotherapy (IMRT) / Volume Modulated Arc Therapy (VMAT).

Detailed description

The study treatment is radiotherapy. Different doses of radiotherapy will be given to patients. The first group of patients will receive the lowest dose (dose level 1) (this is the dose delivered to patients as standard of care). If the treatment does not cause serious side effects, it will be given to the next group of patients enrolled at a higher dose (dose level 2) (this is called 'dose escalation'). If this higher dose of treatment does not cause serious side effects, the next group of patients will receive a higher dose (dose level 3). The doses will continue to increase for every group of patients, as long as no serious side effects occur. If this happens, the study is halted. Once the optimum dose level has been reached, a larger cohort of patients will all receive this dose. Phase I: A 3+3 dose escalation design is proposed to determine the maximum tolerated dose (MTD) defined by the number of radiotherapy-related ≥ Grade 3 acute toxicities assessed up to 4 weeks post RT. Three cohorts of between 3 and 6 patients at each dose level will be accrued in order to establish the MTD (minimum of 6, maximum of 18 patients). The MTD defined in Phase I will be the dose which will be used in Phase II of the trial. Phase II: 49 patients: Once the MTD is established, patients will continue to be recruited at that dose level up to a total of 49 patients.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Dose-Painted Intensity Modulated Radiotherapy	Fifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT/ VMAT. Cohort 1 (n = 3-6) Single PTV 40.05 Gy/15#, homogenous dose. Cohort 2 (n = 3-6) High Risk PTV 45 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions. Cohort 3 (n = 3-6) High risk PTV 48 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions.

Timeline

• Start date: 2024-01-30
• Primary completion: 2027-07-01
• Completion: 2031-07-01
• First posted: 2023-09-06
• Last updated: 2025-07-20

Locations

2 sites across 1 country: Ireland