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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| entire cohort | none (observational study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational | Other | none (observational study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| acute toxicity | physician-related acute toxicity | 3 months |
| late toxicity | physician-related late toxicity | 6, 12, 24, 36, 48, 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients receiving routine SBRT to 1-3 intrahepatic HCC lesions
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Falk Roeder, MD | Contact | +49 89 4400 73729 | Falk.Roeder@med.uni-muenchen.de | |
| Sabine Gerum, MD | Contact | +49 89 4400 73729 | Sabine.Gerum@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Falk Roeder, MD | Department of Radiation Oncology, University Hospital, LMU Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, University Hospital, LMU Munich | Recruiting | Munich | Bavaria | 81377 | Germany |
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| response | response to treatment according to imaging | 3 months |
| local control | absence of regrowth inside the treated lesion | 60 months |
| hepatic control | absence of regrowth or onset of new lesions inside the liver | 60 months |
| distant control | absence of extrahepatic progression | 60 months |
| freedom from treatment failure | absence of disease progression other than death | 60 months |
| overall survival | absence of death of any cause | 60 months |
| pattern of recurrence | pattern of recurrence | 60 months |
| correlation Qol with acute toxicity | correlation Qol with acute toxicity | 3 months |
| correlation Qol with late toxicity | correlation Qol with late toxicity | 6, 12, 24, 36, 48, 60 months |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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