A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma

NCT05203120 | Recruiting

• 1 other identifier: DCPT HCC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of deaths of any cause

  Death of any cause

  4 months after start of radiotherapy

• Number of participants with Radiation-induced liver disease (RILD)

  Worsening of the Child- Pugh score ≥2 or alanin-aminotransferase (ALAT) ≥5 upper normal limit (ULN)

  4 months after start of radiotherapy

Secondary Outcomes (12)

• Number of participants with RILD within 6 months of start of radiotherapy

  6 months after start of radiotherapy

• Acute toxicity

  4 months after start of radiotherapy

• Late toxicity

  from 4 months until 60 months after start of radiotherapy

• Radiation-induced hospitalization

  within 4 months after start of radiotherapy

• Health-related Quality of Life C30

  Until 60 months after start of radiotherapy

Study Arms (1)

Proton Arm

EXPERIMENTAL

All patients in the study will receive proton therapy with 67.5 Gray/15 fractions(fx) /5fx per week .

Radiation: Proton therapy

Interventions

Proton therapy RADIATION

All patients will receive proton therapy 67.5Gy/15fx

Proton Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• University of Aarhus: lead
• Herlev Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• University of Leeds: collaborator
• Aarhus University Hospital: collaborator

Study Sites (3)

Herlev Hospital

Herlev, Capital Region, 2730, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Odense University Hospital

Odense, Syd, 5000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Britta Weber, MD PhD

  Danish Center of Particle Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Britta Weber, MD PhD

CONTACT

+4526236694; britta.weber@auh.rm.dk

Hanna R Mortensen, MD PhD

CONTACT

+45 92432382; hanna.mortensen@auh.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: National phase II non-randomized single-arm study of proton therapy in patients with hepatocellular carcinoma.

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 24, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)