Hepatocellular CancerLIVERCARENCT03253536
Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
An observational study of Hepatocellular Cancer and Quality of Life, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer, Quality of Life, Stereotactic Body Radiation Therapy
- What is being tested?
- observational
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jul 2017to 10 Jul 2027
- Phase
- Observational
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
- Adult, Older adult
Study population: adult patients receiving routine SBRT to 1-3 intrahepatic HCC lesions
Who may be able to join
- histologically or radiologically proven hepatocellular carcinoma
- 1-3 lesions suitable for stereotactic radiation therapy
- indication for SBRT according to multidisciplinary board evaluation
- age >= 18 years
- written informed consent for study participation
- mental and verbal ability to complete standardized questionaires according to assessment by investigator (physician)
Who cannot join
- age < 18 years
- prior HCC specific systemic therapy
- concurrent oncological systemic treatment
- distant metastases
- inadequate ability tobe compliant with the protocol or to complete standardizes questionaires
- inability to receive contrast-enhanced planning CT
- missing ability to give informed consent
- legal custody
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, University Hospital, LMU Munich
Munich, Bavaria, 81377
Falk Roeder, MD, +49 89 4400 73729, Falk.Roeder@med.uni-muenchen.de
Sabine Gerum, MD, +49 89 4400 73729, Sabine.Gerum@med.uni-muenchen.de
About this study
Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. Qol will be measured by standardized and validated EORTC questionaires at different time points during routine follow-up.
Read the detailed description
Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy (SBRT) for patients with hepatocellular cancer (HCC). Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. This will include contrast-enhanced liver MRI or CT and placement of fiducials if necessary. Radiation treatment planning will be based on contrast-enhanced fourdimensional computed tomography (4D-CT) with abdominal compression. Target volume definition will use an internal target volume (ITV) concept. Dose prescription and fractionation will be prescribed individually based on lesion size, localisation, movement and liver function according to institutional standards. Qol will be measured by standardized and validated EORTC questionaires (QLQ C-30 and HCC 18) at baseline, at the end of SBRT, during follow up at 6 weeks, 3,6,12,24,36,48 and 60 months.
- Conditions
- Hepatocellular Cancer, Quality of Life, Stereotactic Body Radiation Therapy, Observational
- Being tested
- observational
- Keywords
- Hepatocellular Cancer, Quality of Life, stereotactic body radiation therapy, observational
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
none (observational study)
| Study group | Role | What they receive |
|---|---|---|
| entire cohort | none (observational study) Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life
Measured: 60 months
Secondary outcomes (11)
acute toxicity
physician-related acute toxicity
Measured: 3 months
late toxicity
physician-related late toxicity
Measured: 6, 12, 24, 36, 48, 60 months
response
response to treatment according to imaging
Measured: 3 months
local control
absence of regrowth inside the treated lesion
Measured: 60 months
hepatic control
absence of regrowth or onset of new lesions inside the liver
Measured: 60 months
distant control
absence of extrahepatic progression
Measured: 60 months
freedom from treatment failure
absence of disease progression other than death
Measured: 60 months
overall survival
absence of death of any cause
Measured: 60 months
pattern of recurrence
pattern of recurrence
Measured: 60 months
correlation Qol with acute toxicity
correlation Qol with acute toxicity
Measured: 3 months
correlation Qol with late toxicity
correlation Qol with late toxicity
Measured: 6, 12, 24, 36, 48, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start10 Jul 2017
- Primary completion10 Jul 2022 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Falk Roeder, Ludwig-Maximilians - University of Munich
- Investigators
- Falk Roeder, MD, Principal investigator, Department of Radiation Oncology, University Hospital, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253536
- Sponsor's protocol ID
- Livercare
- Acronym
- LIVERCARE
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No