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

Ludwig Maximilian University of Munich

Status: Enrolling

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

Treatments: Other: observational

Study type: Observational

Funder types: Other

Identifiers

NCT03253536

Livercare

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

entire cohort

Description:

none (observational study)

Treatment:

Other: observational