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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
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrahypofractionation Phase | Experimental | MR-Guided Ultrahypofractionation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-guided Irradiation | Radiation | MR-guided Irradiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | A. To achieve a 1-year survival of 85%. | 2-years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To decrease grade 4-5 gastrointestinal events to less than 5%. | 2-years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Ramos Aguirre, M.S. | Contact | +34 948255400 | 2772 | ucicec@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Rafael MartÃnez-Monge, M.D. | ClÃnica Universidad de Navarra | Principal Investigator |
| Luis Fuertes, M.D. | ClÃnica Universidad de Navarra | Principal Investigator |
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On request
5-years
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |