A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Patients with past or ongoing hepatitis C infection are allowed, but treatment for hepatitis C must have been completed one month before study entry * Patients with hepatitis B infection is allowed if antiviral therapy have been given for at least 4 weeks and Hepatitis B Virus (HBV) viral load is less than 100 IU/ml. The active therapy must continue throug