Trials / Recruiting
RecruitingNCT03253536
Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Ludwig-Maximilians - University of Munich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | observational | none (observational study) |
Timeline
- Start date
- 2017-07-10
- Primary completion
- 2022-07-10
- Completion
- 2027-07-10
- First posted
- 2017-08-18
- Last updated
- 2017-08-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03253536. Inclusion in this directory is not an endorsement.