RecruitingNot ApplicableNCT05191940

Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

Phase II Trial of Hypo-fractionated Highly Conformal Radiotherapy for Locally Advanced Pancreatic Carcinomas


Sponsor

EBG MedAustron GmbH

Enrollment

30 participants

Start Date

May 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial is studying the use of radiation therapy in patients with locally advanced pancreatic cancer that cannot be surgically removed and is no longer responding to, or not eligible for, chemotherapy. The goal is to determine whether radiation can help control the disease. **You may be eligible if...** - You are over 18 years old with confirmed pancreatic cancer that cannot be surgically removed - Your cancer has not spread to distant organs - You are no longer a candidate for chemotherapy (due to disease progression or poor tolerance) - Your overall health score (Karnofsky index) is 70 or above **You may NOT be eligible if...** - Your cancer has spread to other organs beyond the pancreas - You have a non-pancreatic exocrine tumor - You have had prior abdominal radiation therapy - You are pregnant or breastfeeding - You have severe liver or kidney impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONParticle-therapy using protons or carbon ions

According to the radiation plan (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).

DIAGNOSTIC_TESTBlood sampling

Evaluation before treatment-start, after treatment and follow-up period.

DIAGNOSTIC_TESTMagnetic resonance imaging

For treatment planning as well as for follow-up radiological tumor assessment.

DIAGNOSTIC_TESTComputertomography

For treatment planning as well as for follow-up radiological tumor assessment.

DIAGNOSTIC_TEST18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)

For treatment planning as well as for follow-up radiological tumor assessment.


Locations(1)

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, Austria

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NCT05191940


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