Viewing Study NCT06024824



Ignite Creation Date: 2024-05-06 @ 7:28 PM
Last Modification Date: 2024-10-26 @ 3:07 PM
Study NCT ID: NCT06024824
Status: RECRUITING
Last Update Posted: 2024-02-23
First Post: 2023-06-16

Brief Title: Dose-Painted Intensity Modulated Radiotherapy Pancreas DP-IMRT Pancreas
Sponsor: Cancer Trials Ireland
Organization: Cancer Trials Ireland

Study Overview

Official Title: DP-IMRT Pancreas A Non-randomised Phase III Study of Dose-escalated Hypofractionated Dose-Painted Intensity Modulated Radiotherapy DPIMRT in ResectableBorderline Resectable Pancreatic Adenocarcinoma
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a prospective non-randomised Phase III 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 33 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None