Clinical trial NCT03253536: Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
Official title: Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Cancer
Quality of Life
Stereotactic Body Radiation Therapy
Observational
Keywords: Hepatocellular Cancer
Quality of Life
stereotactic body radiation therapy
observational
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients receiving routine SBRT to 1-3 intrahepatic HCC lesions

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: 60 months
Secondary outcomes:
measure: acute toxicity
timeFrame: 3 months
measure: late toxicity
timeFrame: 6, 12, 24, 36, 48, 60 months
measure: response
timeFrame: 3 months
measure: local control
timeFrame: 60 months
measure: hepatic control
timeFrame: 60 months
measure: distant control
timeFrame: 60 months
measure: freedom from treatment failure
timeFrame: 60 months
measure: overall survival
timeFrame: 60 months
measure: pattern of recurrence
timeFrame: 60 months
measure: correlation Qol with acute toxicity
timeFrame: 3 months
measure: correlation Qol with late toxicity
timeFrame: 6, 12, 24, 36, 48, 60 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Radiation Oncology, University Hospital, LMU Munich
state: Bavaria
Study officials:
affiliation: Department of Radiation Oncology, University Hospital, LMU Munich
name: Falk Roeder, MD
role: PRINCIPAL_INVESTIGATOR
References: