NCT07132060

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
51mo left

Started Oct 2025

Typical duration for not_applicable pancreatic-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Oct 2025Jun 2030

First Submitted

Initial submission to the registry

August 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

4.7 years

First QC Date

August 12, 2025

Last Update Submit

August 20, 2025

Conditions

Pancreatic Cancer

Keywords

MRI-guided irradiationDose escalationUltrahypofractionation

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

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

    2-years

Secondary Outcomes (1)

  • Adverse Events

    2-years

Study Arms (1)

Ultrahypofractionation Phase

EXPERIMENTAL

MR-Guided Ultrahypofractionation

Radiation: MR-guided Irradiation

Interventions

MR-guided IrradiationRADIATION

MR-guided Irradiation

Ultrahypofractionation Phase

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to undergo an MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Rafael Martínez-Monge, M.D.

    Clínica Universidad de Navarra

    PRINCIPAL INVESTIGATOR

  • Luis Fuertes, M.D.

    Clínica Universidad de Navarra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Ramos Aguirre, M.S.

CONTACT

+34 948255400ucicec@unav.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 20, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

On request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
5-years
Access Criteria
On request