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

Recruiting

• Conditions: Hepatocellular Cancer; Quality of Life; Stereotactic Body Radiation Therapy; 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.

Study Timeline

• Study Start: 2017-07-10
• Status Verified: 2017-08
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-16
• Last Update Submitted: 2017-08-16
• Study First Posted: 2017-08-18
• Last Update Posted: 2017-08-18
• Primary Completion: 2022-07-10
• Study Completion: 2027-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life	60 months	Quality of life

Secondary Outcome Measures

Name	Time	Method
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
freedom from treatment failure	60 months	absence of disease progression other than death
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