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NCT05203120

A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma

Recruiting now NA Last updated 11 May 2023
What this trial tests

NA trial testing Proton therapy in Hepatocellular Carcinoma in 50 participants. Currently enrolling.

Timeline
1 April 2022
Primary endpoint
31 December 2025
1 January 2030

Quick facts

Lead sponsorUniversity of Aarhus
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date1 April 2022
Primary completion31 December 2025
Estimated completion1 January 2030
Sites3 locations across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Predictive Model of Liver Toxicity to Aid the Personalized Selection of Proton Versus Photon Therapy in Hepatocellular Carcinoma.
    Chamseddine I, Kim Y, De B, Naqa IE, et al · · 2023 · cited 10× · PMID 36739920 · DOI 10.1016/j.ijrobp.2023.01.055
  2. Intrafraction tumor motion monitoring and dose reconstruction for liver pencil beam scanning proton therapy.
    Nankali S, Worm ES, Thomsen JB, Stick LB, et al · · 2023 · cited 7× · PMID 36937392 · DOI 10.3389/fonc.2023.1112481
  3. Proton therapy in the treatment of hepatocellular carcinoma.
    Dionisi F, Scartoni D, Fracchiolla F, Giacomelli I, et al · · 2022 · cited 2× · PMID 36003769 · DOI 10.3389/fonc.2022.959552

Verify or expand the search:

Other trials of Proton therapy

Trials testing the same drug.

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other University of Aarhus trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05203120.

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