MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer

N/ANot Yet RecruitingNCT07132060

Clinica Universidad de Navarra, Universidad de Navarra30 enrolled

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

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 .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

MR-guided IrradiationRADIATION

MR-guided Irradiation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival

A. To achieve a 1-year survival of 85%.

Time frame: 2-years

Secondary Outcomes

Adverse Events

To decrease grade 4-5 gastrointestinal events to less than 5%.

Time frame: 2-years

Central Contacts

Beatriz Ramos Aguirre, M.S.

CONTACT

+34 948255400 ucicec@unav.es

Data from ClinicalTrials.gov

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