NCT03253536 Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
| NCT ID | NCT03253536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ludwig-Maximilians - University of Munich |
| Condition | Hepatocellular Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-07-10 |
| Primary Completion | 2022-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2017-07-10 with a primary completion date of 2022-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Falk Roeder, MD
PRINCIPAL INVESTIGATOR
Department of Radiation Oncology, University Hospital, LMU Munich
Frequently Asked Questions
Who can join the NCT03253536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03253536 currently recruiting?
Yes, NCT03253536 is actively recruiting participants. Contact the research team at Falk.Roeder@med.uni-muenchen.de for enrollment information.
Where is the NCT03253536 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT03253536 clinical trial?
NCT03253536 is sponsored by Ludwig-Maximilians - University of Munich. The principal investigator is Falk Roeder, MD at Department of Radiation Oncology, University Hospital, LMU Munich. The trial plans to enroll 100 participants.
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