Hepatocellular Cancer, Observational, Quality of Life, Stereotactic Body Radiation Therapy
Conditions
Keywords
Hepatocellular Cancer, Quality of Life, stereotactic body radiation therapy, observational
Brief 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.
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.
Interventions
OTHERobservational
none (observational study)
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 60 months | Quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hepatic control | 60 months | absence of regrowth or onset of new lesions inside the liver |
| acute toxicity | 3 months | physician-related acute toxicity |
| late toxicity | 6, 12, 24, 36, 48, 60 months | physician-related late toxicity |
| response | 3 months | response to treatment according to imaging |
| distant control | 60 months | absence of extrahepatic progression |
| local control | 60 months | absence of regrowth inside the treated lesion |
| overall survival | 60 months | absence of death of any cause |
| pattern of recurrence | 60 months | pattern of recurrence |
| correlation Qol with acute toxicity | 3 months | correlation Qol with acute toxicity |
| correlation Qol with late toxicity | 6, 12, 24, 36, 48, 60 months | correlation Qol with late toxicity |
| freedom from treatment failure | 60 months | absence of disease progression other than death |
Countries
Germany
Contacts
Primary ContactFalk Roeder, MD
Backup ContactSabine Gerum, MD
Outcome results
None listed