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
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03253536
- Acronym / sponsor ID
- LIVERCARE / Livercare
- Conditions
- Hepatocellular Cancer, Quality of Life, Stereotactic Body Radiation Therapy, Observational
- Keywords
- Hepatocellular Cancer, Quality of Life, stereotactic body radiation therapy, observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 10 Jul 2022 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| entire cohort | – | Other: observationalnone (observational study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients receiving routine SBRT to 1-3 intrahepatic HCC lesions
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalnone (observational study) | Other | entire cohort |
Primary outcome
Quality of life
Time frame: 60 months
Quality of life
11 secondary outcomes
acute toxicity
Time frame: 3 months
late toxicity
Time frame: 6, 12, 24, 36, 48, 60 months
response
Time frame: 3 months
local control
Time frame: 60 months
hepatic control
Time frame: 60 months
distant control
Time frame: 60 months
freedom from treatment failure
Time frame: 60 months
overall survival
Time frame: 60 months
pattern of recurrence
Time frame: 60 months
correlation Qol with acute toxicity
Time frame: 3 months
correlation Qol with late toxicity
Time frame: 6, 12, 24, 36, 48, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Falk Roeder, MD principal investigator
Department of Radiation Oncology, University Hospital, LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Cancer and Quality of Life, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 6 inclusion and 8 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Falk Roeder, MD (+49 89 4400 73729, Falk.Roeder@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2017.