A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Recruiting now · Not applicable
Conditions studied: Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05203120
- Run by
- University of Aarhus
- People needed
- 50
- Starts
- 2022-04-01
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2023-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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 throughout the radiation therapy. Patients who are Total hepatitis B core antibody (anti-HBc)(+), negative for Hepatitis B surface antigen (HbsAg) and negative or positive for Hepatitis B surface antibody (anti-HBs) with a HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis
- Adequate organ function
- hematological: hemoglobin ≥ 6 mmol/l, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 50 x 109/L
- hepatic: bilirubin ≤ 1.5 x ULN, alanin-aminotransferase (ALAT) ≤ 1.5 x ULN
- renal: creatinine ≤ 1.5 x ULN
- Ability to adhere to procedures for study and follow-up
- Signed informed consent to participate
- Final decisions on inclusion and treatment with proton therapy are at the discretion of the investigator
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)
- Patients for whom it is not possible to produce a robust treatment plan following the technical guidelines (Appendix A)
- Patients for whom it is not possible to implant fiducial markers e.g. due to insufficient coagulation of the blood.
Where it is running
- Herlev Hospital — Herlev, Capital Region, Denmark (enrolling)
- Aarhus University Hospital — Aarhus, Central Jutland, Denmark (enrolling)
- Odense University Hospital — Odense, Syd, Denmark
Full record on ClinicalTrials.gov
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