MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MR-guided Irradiation.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 .
Interventions
- Radiation MR-guided Irradiation
MR-guided Irradiation
Primary outcome measures
- Overall Survival [Time frame: 2-years]
Secondary outcome measures (1)
- Adverse Events [Time frame: 2-years]
Eligibility criteria
Inclusion criteria
- Selection criteria includes patients with unresectable and borderline resectable and medically inoperable pancreatic cancer that will receive neoadjuvant chemotherapy followed by chemoirradiation.
- No prior radiation therapy to the target areas;
- Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including neoadjuvant chemotherapy followed by chemoirradiation.
- WBC equal or greater than 3500 mm\^3; platelet count equal or greater than 135000 mm\^3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
Exclusion criteria
- Inability to undergo an MRI scan
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07132060 · 2024.174