AzTrials
AzTrials

Hepatocellular CarcinomaNCT05203120

A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma

A study testing Proton therapy in people with Hepatocellular Carcinoma, run by University of Aarhus at 3 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Proton therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesDenmark
Study dates
1 Apr 2022to 1 Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Britta Weber, MD PhD contact

+4526236694

britta.weber@auh.rm.dk

Hanna R Mortensen, MD PhD contact

+45 92432382

hanna.mortensen@auh.rm.dk

Denmark3 sites, 3 recruiting

  • Aarhus University Hospital

    Aarhus, Central Jutland, 8200

    Britta Weber, MD PhD, +45 26236694, britta.weber@auh.rm.dk

    Hanna R Mortensen, Md PhD, +45 92432382, hanna.mortensen@auh.rm.dk

    Recruiting

  • Herlev Hospital

    Herlev, Capital Region, 2730

    Mette van Overeem Felter, MD, mette.van.overeem.felter@regionh.dk

    Kirsten Vistisen, MD, Kirsten.Vistisen@regionh.dk

    Recruiting

  • Odense University Hospital

    Odense, Syd, 5000

    Merete Krogh, Merete.Krogh@rsyd.dk

    Annette Fialla

    Not yet recruiting

Other trials in Denmark

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.

Read the 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 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. The study aims to offer curative treatment to a larger group of patients and thus better prognosis for these patients.

The study will include 50 patients enrolled within 3 years. Patients cannot be guaranteed any direct personal benefits of participating in the trial. Participating in the study can help with new knowledge that can benefit future patients with similar illness.

The treatment will be given at the Danish Center for Particle Therapy. During radiotherapy, additional CT scans will be performed weekly as part of quality assurance until it can be documented that there is no such need.

Participation in the study will also mean additional examinations and questionnaires at the start of treatment, below treatment and at follow-up.

All patients will be asked to supply blood samples to analyze for circulating tumor DNA.

Being tested
Proton therapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton therapyRadiation

    All patients will receive proton therapy 67.5Gy/15fx

Study groups in NCT05203120
Study groupRoleWhat they receive
Proton ArmExperimentalAll patients in the study will receive proton therapy with 67.5 Gray/15 fractions(fx) /5fx per week .
Receives: Radiation: Proton therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of deaths of any cause

    Death of any cause

    Measured: 4 months after start of radiotherapy

  2. 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)

    Measured: 4 months after start of radiotherapy

Secondary outcomes (12)

  1. Number of participants with RILD within 6 months of start of radiotherapy

    Worsening of the Child- Pugh score ≥2 or ALAT ≥5 ULN

    Measured: 6 months after start of radiotherapy

  2. Acute toxicity

    Number of participants with Acute radiation-related toxicity grade 3 or higher measured by CTCAE v5.0

    Measured: 4 months after start of radiotherapy

  3. Late toxicity

    Number of participants with Late radiation-related toxicity grade 3 or higher measured by CTCAE v5.0

    Measured: from 4 months until 60 months after start of radiotherapy

  4. Radiation-induced hospitalization

    Number of days spend in the hospital due to radiotherapy toxicity

    Measured: within 4 months after start of radiotherapy

  5. Health-related Quality of Life C30

    Health-related Quality of life measured by the EORTC QoL questionnaires C30

    Measured: Until 60 months after start of radiotherapy

  6. Quality of Life HCC-18

    Health-related Quality of life measured by the EORTC QoL questionnaires HCC18

    Measured: Until 60 months after start of radiotherapy

  7. Local control

    1- and 3-year local control

    Measured: 3 years after start of radiotherapy

  8. Progression-free survival

    1- and 3-year progression-free survival

    Measured: 3 years after start of radiotherapy

  9. Overall survival

    1- and 3-year overall survival

    Measured: 3 years after start of radiotherapy

  10. Pattern of failure

    Pattern of failure will be reported as number of patients with in-field failures in the clinical target volumen (CTV), in-field failures in the planning target volume (PTV), and out-of-field failures.

    Measured: Until 5 years after start of radiotherapy

  11. Technical feasibility

    the proportion of patients where it was possible to adhere to the guidelines of CTV dose coverage and tolerable normal tissue dose

    Measured: up to 5 years

  12. Reduction in mean liver dose

    calculated on a per patient basis, and median (and inter-quartile ranged) will be reported for the study population.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start1 Apr 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
National phase II non-randomized single-arm study of proton therapy in patients with hepatocellular carcinoma.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203120
Sponsor's protocol ID
DCPT HCC
Status last verified
May 2023
First submitted
13 Dec 2021
Last updated
11 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Proton therapy in people with Hepatocellular Carcinoma, run by University of Aarhus at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Britta Weber, MD PhD (+4526236694, britta.weber@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of deaths of any cause (time frame: 4 months after start of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05203120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in