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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03253536
Other study ID # Livercare
Secondary ID
Status Recruiting
Phase N/A
First received August 14, 2017
Last updated August 16, 2017
Start date July 10, 2017
Est. completion date July 10, 2027

Study information

Verified date August 2017
Source Ludwig-Maximilians - University of Munich
Contact Falk Roeder, MD
Phone +49 89 4400 73729
Email Falk.Roeder@med.uni-muenchen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Qol will be measured by standardized and validated EORTC questionaires at different time points during routine follow-up.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 10, 2027
Est. primary completion date July 10, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observational
none (observational study)

Locations

Country Name City State
Germany Department of Radiation Oncology, University Hospital, LMU Munich Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life Quality of life 60 months
Secondary acute toxicity physician-related acute toxicity 3 months
Secondary late toxicity physician-related late toxicity 6, 12, 24, 36, 48, 60 months
Secondary response response to treatment according to imaging 3 months
Secondary local control absence of regrowth inside the treated lesion 60 months
Secondary hepatic control absence of regrowth or onset of new lesions inside the liver 60 months
Secondary distant control absence of extrahepatic progression 60 months
Secondary freedom from treatment failure absence of disease progression other than death 60 months
Secondary overall survival absence of death of any cause 60 months
Secondary pattern of recurrence pattern of recurrence 60 months
Secondary correlation Qol with acute toxicity correlation Qol with acute toxicity 3 months
Secondary correlation Qol with late toxicity correlation Qol with late toxicity 6, 12, 24, 36, 48, 60 months
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