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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Hepatocellular Cancer; Stereotactic Body Radiation Therapy; Observational
• Intervention / Treatment: Other: observational

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Falk Roeder, MD; Phone Number: +49 89 4400 73729; Email: Falk.Roeder@med.uni-muenchen.de
• Study Contact Backup: Name: Sabine Gerum, MD; Phone Number: +49 89 4400 73729; Email: Sabine.Gerum@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Department of Radiation Oncology, University Hospital, LMU Munich
      • Sub-Investigator: Franziska Walter, MD
      • Sub-Investigator: Michael Hoffmann, MD
      • Sub-Investigator: Alexandra Jensen, MD
      • Contact: Falk Roeder, MD; Phone Number: +49 89 4400 73729; Email: Falk.Roeder@med.uni-muenchen.de
      • Contact: Sabine Gerum, MD; Phone Number: +49 89 4400 73729; Email: Sabine.Gerum@med.uni-muenchen.de
      • Sub-Investigator: Ladan Saleh-Ebrahimi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients receiving routine SBRT to 1-3 intrahepatic HCC lesions

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
entire cohort; none (observational study)	Other: observational; none (observational study)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Falk Roeder, MD, Department of Radiation Oncology, University Hospital, LMU Munich

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): July 10, 2022
• Study Completion (Anticipated): July 10, 2027

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Quality of Life; observational; Hepatocellular Cancer; stereotactic body radiation therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: LiverCare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No