Pancreatic Cancer
Conditions
Keywords
MRI-guided irradiation, Dose escalation, Ultrahypofractionation
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 .
Interventions
RADIATIONMR-guided Irradiation
MR-guided Irradiation
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2-years | A. To achieve a 1-year survival of 85%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 2-years | To decrease grade 4-5 gastrointestinal events to less than 5%. |
Contacts
Primary ContactBeatriz Ramos Aguirre, M.S.
Outcome results
None listed