Status:
RECRUITING
A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Herlev Hospital
Rigshospitalet, Denmark
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Each year, approximately 350 new cases of hepatocellular carcinoma (HCC) are diagnosed in Denmark, but the overall prognosis is poor with a 1-year survival rate of less than 40% and a 5-year survival ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05203120
Start Date
April 1 2022
End Date
January 1 2030
Last Update
May 11 2023
Active Locations (3)
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1
Herlev Hospital
Herlev, Capital Region, Denmark, 2730
2
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200
3
Odense University Hospital
Odense, Syd, Denmark, 5000