Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma

Conditions
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Hepatocellular Cancer, Quality of Life, Stereotactic Body Radiation Therapy, Observational

Intervention / Treatment
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* Other: observational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| entire cohort<br>none (observational study) | Other: observational<br>* none (observational study)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life | 60 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Cancer, Quality of Life, stereotactic body radiation therapy, observational