Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT07132060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Organization:
Study Overview
Official Title:
MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
The goal of this clinical trial is to learn if the use of dose-escalated MRI-guided irradiation increases the rates of disease control in patients with pancreatic cancer
Detailed Description:
The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Pancreatic Cancer Intensification Program maximizes treatment objectives rates due to the better visualization and online dose-adaptation pancreatic tumor.
Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen (Henke et al., 2018). This creates a much better CTV to OAR ratio in a 50Gy/5Rx scenario.
Primary Objectives A. To achieve a 1-year survival of 85%. B. To decrease grade 4-5 gastrointestinal events to less than 5%.
Secondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .
B. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of quality of life with the EORTC QLQ-C30 Questionnaire .
Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen (Henke et al., 2018). This creates a much better CTV to OAR ratio in a 50Gy/5Rx scenario.
Primary Objectives A. To achieve a 1-year survival of 85%. B. To decrease grade 4-5 gastrointestinal events to less than 5%.
Secondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .
B. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of quality of life with the EORTC QLQ-C30 Questionnaire .
Study Oversight
Has Oversight DMC:
False
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?: