RecruitingHepatocellular Carcinoma
A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: University of Aarhus
You may qualify if…
- ✓ Patients with HCC based on classical radiologic findings as defined by the American Association for the Study of Liver Diseases (AASLD) criteria or verified by biopsy
- ✓ No extra-hepatic disease
- ✓ Deemed ineligible for resection or Radiofrequency Ablation (RFA), or the patients should refuse RFA or surgery
- ✓ Age ≥ 18 years
- ✓ Performance status ≤ 2
- ✓ Total diameter of tumor(s) ≤ 12 cm and a maximum of 3 tumors
- ✓ Adequate liver function as measured by Child-Pugh score (Child-Pugh score ≤ 8), or absence of cirrhosis
- ✓ Has recovered adequately from toxicity and/or complications from any previous local interventions
You may not qualify if…
- ✕ Previous x-ray-based radiotherapy in the liver
- ✕ Child Pugh score \>8
- ✕ Tumor less than 1 cm from any critical organs at risk (OAR) (duodenum, kidney, stomach, intestines).
- ✕ Previous Selective internal radiation therapy (SIRT)
- ✕ Episode of hepatic encephalopathy within the last 6 months
- ✕ Uncontrolled ascites with need for drainage \> 1 per month
- ✕ Episode of bleeding esophageal varices within the past month. If active bleeding from esophageal varices has occurred, a gastroscopy should be performed 4 weeks after the bleeding episode to ensure maximum grade 1 varices.
- ✕ Patients with metal implants where beam entrance through the metal implants cannot be avoided (not applicable for fiducial markers implanted for radiotherapy use)
Source: ClinicalTrials.gov · NCT05203120 · last updated 2023-05-11