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

Quality of Life Clinical Trial

— LIVERCARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03253536
• Other study ID #: Livercare
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 16, 2017
• Start date: July 10, 2017
• Est. completion date: July 10, 2027

Study information

• Verified date: August 2017
• Source: Ludwig-Maximilians - University of Munich
• Contact: Falk Roeder, MD
• Phone: +49 89 4400 73729
• Email: Falk.Roeder[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 10, 2027
• Est. primary completion date: July 10, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Cancer
• Liver Neoplasms
• Observational
• Quality of Life
• Stereotactic Body Radiation Therapy

Intervention

Other:
• observational
none (observational study)

Locations

Country	Name	City	State
Germany	Department of Radiation Oncology, University Hospital, LMU Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life	60 months
Secondary	acute toxicity	physician-related acute toxicity	3 months
Secondary	late toxicity	physician-related late toxicity	6, 12, 24, 36, 48, 60 months
Secondary	response	response to treatment according to imaging	3 months
Secondary	local control	absence of regrowth inside the treated lesion	60 months
Secondary	hepatic control	absence of regrowth or onset of new lesions inside the liver	60 months
Secondary	distant control	absence of extrahepatic progression	60 months
Secondary	freedom from treatment failure	absence of disease progression other than death	60 months
Secondary	overall survival	absence of death of any cause	60 months
Secondary	pattern of recurrence	pattern of recurrence	60 months
Secondary	correlation Qol with acute toxicity	correlation Qol with acute toxicity	3 months
Secondary	correlation Qol with late toxicity	correlation Qol with late toxicity	6, 12, 24, 36, 48, 60 months