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
404 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
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
Official Title
A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with hepatocellular carcinoma by standard radiologic criteria or biopsy
- No cancer spread outside the liver
- Not eligible for surgical removal or radiofrequency ablation, or have refused these treatments
- Age 18 years or older
- Performance status of 2 or less
- Total tumor size 12 cm or less, with no more than 3 tumors
- Adequate liver function measured by Child-Pugh score 8 or less, or no cirrhosis
- Recovered from side effects of any prior local treatments
- Completed hepatitis C treatment at least one month before study entry if previously or currently infected
- If infected with hepatitis B, antiviral therapy must have been given for at least 4 weeks and viral load under 100 IU/ml; therapy must continue during radiation
- Adequate blood counts, liver enzymes, and kidney function
- Able to follow study procedures and attend follow-up
- Provided signed informed consent
- Final inclusion and treatment decisions are made by the investigator
You will not qualify if you...
- Previous x-ray based radiotherapy to the liver
- Child-Pugh score greater than 8
- Tumor 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 requiring drainage more than once per month
- Recent bleeding from esophageal varices within the past month without follow-up gastroscopy
- Metal implants blocking radiation beam entry (except fiducial markers)
- Unable to create a safe treatment plan according to technical guidelines
- Unable to implant fiducial markers due to blood clotting issues or other reasons
AI-Screening
AI-Powered Screening
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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
CONTACT
H
Hanna R Mortensen, MD PhD
CONTACT
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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