A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma

NCT05203120 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Proton therapy

All patients will receive proton therapy 67.5Gy/15fx

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • University of Leeds

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Britta Weber, MD PhD · Danish Center of Particle Therapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-12-31
Completion
2030-01-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203120 on ClinicalTrials.gov