Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
- Conditions
- Hepatocellular CancerQuality of LifeStereotactic Body Radiation TherapyObservational
- Interventions
- Other: observational
- Registration Number
- NCT03253536
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description entire cohort observational none (observational study)
- Primary Outcome Measures
Name Time Method Quality of life 60 months Quality of life
- Secondary Outcome Measures
Name Time Method freedom from treatment failure 60 months absence of disease progression other than death
hepatic control 60 months absence of regrowth or onset of new lesions inside the liver
overall survival 60 months absence of death of any cause
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
local control 60 months absence of regrowth inside the treated lesion
pattern of recurrence 60 months pattern of recurrence
distant control 60 months absence of extrahepatic progression
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
Trial Locations
- Locations (1)
Department of Radiation Oncology, University Hospital, LMU Munich
🇩🇪Munich, Bavaria, Germany