RecruitingNot ApplicableNCT05203120

A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma


Sponsor

University of Aarhus

Enrollment

50 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

350 new cases of hepatocellular carcinoma (HCC) are diagnosed in Denmark each year, but the overall prognosis is poor with a 1-year survival rate of less than 40% and a 5-year survival rate of 10% for the entire patient group. This national phase II non-randomized single-arm study of proton therapy in HCC is conducted with the aim to offer a safe and efficient radiation treatment to fragile patients with reduced dose to the normal liver compared to conventional photon-based radiotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This national study is testing proton therapy — a precise form of radiation that targets tumors while sparing surrounding tissue — for patients with liver cancer (hepatocellular carcinoma, HCC) who cannot have surgery or standard ablation procedures. **You may be eligible if...** - You are 18 or older - You have been diagnosed with liver cancer (HCC) confirmed by imaging or biopsy - Your cancer is confined to the liver (no spread outside the liver) - You are not eligible for surgery or ablation, or you prefer not to have those procedures - You have no more than 3 tumors with a total diameter of 12 cm or less - Your liver function is adequate (Child-Pugh score of 8 or less) **You may NOT be eligible if...** - Your liver cancer has spread outside the liver - You have more than 3 liver tumors or very large tumors - Your liver function is severely impaired - You have had recent treatment that hasn't healed adequately 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

RADIATIONProton therapy

All patients will receive proton therapy 67.5Gy/15fx


Locations(3)

Herlev Hospital

Herlev, Capital Region, Denmark

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Odense University Hospital

Odense, Syd, Denmark

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NCT05203120


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