MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorClinica Universidad de Navarra, Universidad de Navarra

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Inability to undergo an MRI scan

Trial design

Design model

Single group

Treatments tested in this trial

  • MR-guided Irradiation

    Radiation

    MR-guided Irradiation

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Ultrahypofractionation PhaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

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

Time frame
2-years

Secondary outcomes

1

Adverse Events

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

Time frame
2-years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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