Actively Recruiting
A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Led by University of Aarhus · Updated on 2023-05-11
50
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
H
Herlev Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating proton therapy as a treatment for hepatocellular carcinoma (HCC), a type of liver cancer that has a poor prognosis with low survival rates. The study is a national phase II, non-randomized, single-arm trial designed to offer a safer and more effective radiation treatment for fragile patients by reducing the radiation dose to the healthy liver compared to traditional photon-based radiotherapy. The goal is to provide curative treatment to more patients and improve their outlook. All participants will receive proton therapy with a total dose of 67.5 Gray delivered in 15 treatment sessions over three weeks (5 sessions per week) at the Danish Center for Particle Therapy. Weekly CT scans will be performed during treatment for quality assurance until no further scans are deemed necessary. The treatment is provided under careful medical supervision and aims to minimize harm to surrounding healthy tissue. Participants will be involved in additional evaluations including blood samples for circulating tumor DNA analysis, questionnaires, and extra examinations before, during, and after treatment. Researchers will monitor safety outcomes such as deaths, radiation-induced liver disease, liver toxicity, hospitalizations, tumor control, quality of life, and survival over a follow-up period of up to five years. The total enrollment period is three years with ongoing assessments to understand long-term effects and treatment feasibility.
CONDITIONS
Brief Title
A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hepatocellular carcinoma confirmed by imaging or biopsy
- No cancer spread outside the liver
- Not eligible for or have refused surgery or radiofrequency ablation
- Age 18 years or older
- Performance status of 2 or less
- Tumor size total diameter 12 cm or less, with a maximum of 3 tumors
- Adequate liver function (Child-Pugh score 8 or less) or no cirrhosis
- Recovered from toxicity or complications from previous local treatments
- Completed hepatitis C treatment at least one month before study entry if infected
- For hepatitis B infection, antiviral therapy for at least 4 weeks and viral load under 100 IU/ml, with continued therapy during radiation
- Adequate blood counts, liver enzymes, and kidney function
- Able to follow study procedures and attend follow-up
- Signed informed consent
You will not qualify if you...
- Previous x-ray based radiotherapy to the liver
- Child-Pugh score greater than 8
- Tumor located less than 1 cm from critical organs like duodenum, kidney, stomach, or intestines
- Previous selective internal radiation therapy (SIRT)
- Hepatic encephalopathy episode within the last 6 months
- Uncontrolled ascites needing drainage more than once per month
- Bleeding esophageal varices episode within the last month without follow-up gastroscopy
- Metal implants blocking radiation beam entry (except fiducial markers for radiotherapy)
- Unable to produce a robust treatment plan as per technical guidelines
- Unable to implant fiducial markers due to blood coagulation issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive proton therapy consisting of 67.5 Gray delivered in 15 fractions over 3 weeks. Weekly CT scans are performed during radiotherapy as part of quality assurance.
5 treatment visits per week with weekly CT scans
Duration - Up to 5 years
Participants have additional examinations, questionnaires, and blood sample collections to monitor outcomes and safety after treatment ends.
Regular follow-up visits including blood sampling and questionnaires
Trial Site Locations
Total: 3 locations
1
Herlev Hospital
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
3
Odense University Hospital
Odense, Syd, Denmark, 5000
Not Yet Recruiting
Research Team
B
Britta Weber, MD PhD
H
Hanna R Mortensen, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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