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Recruiting NCT03253536

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

— Observational Hepatocellular Cancer Quality of Life Stereotactic Body Radiation Therapy Observational

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational.
Who it may be relevant to
Registry conditions: Hepatocellular Cancer, Quality of Life, Stereotactic Body Radiation Therapy, Observational. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other observational
    none (observational study)

Primary outcome measures

  • Quality of life [Time frame: 60 months]
Secondary outcome measures (11)
  • acute toxicity [Time frame: 3 months]
  • late toxicity [Time frame: 6, 12, 24, 36, 48, 60 months]
  • response [Time frame: 3 months]
  • local control [Time frame: 60 months]
  • hepatic control [Time frame: 60 months]
  • distant control [Time frame: 60 months]
  • freedom from treatment failure [Time frame: 60 months]
  • overall survival [Time frame: 60 months]
  • pattern of recurrence [Time frame: 60 months]
  • correlation Qol with acute toxicity [Time frame: 3 months]
  • correlation Qol with late toxicity [Time frame: 6, 12, 24, 36, 48, 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Department of Radiation Oncology, University Hospital, LMU Munich — Munich

Identifiers

NCT: NCT03253536 · Livercare

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗