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

NCT03253536 | Recruiting

• 1 other identifier: Livercare
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hepatocellular Cancer; Quality of Life; stereotactic body radiation therapy; observational

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Quality of life

  60 months

Secondary Outcomes (11)

• acute toxicity

  3 months

• late toxicity

  6, 12, 24, 36, 48, 60 months

• response

  3 months

• local control

  60 months

• hepatic control

  60 months

Study Arms (1)

entire cohort

none (observational study)

Other: observational

Interventions

observational OTHER

none (observational study)

entire cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients receiving routine SBRT to 1-3 intrahepatic HCC lesions

You may qualify if:

• histologically or radiologically proven hepatocellular carcinoma
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Falk Roeder, MD

  Department of Radiation Oncology, University Hospital, LMU Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Falk Roeder, MD

CONTACT

+49 89 4400 73729; Falk.Roeder@med.uni-muenchen.de

Sabine Gerum, MD

CONTACT

+49 89 4400 73729; Sabine.Gerum@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Radiation Oncology

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 18, 2017
• Study Start: July 10, 2017
• Primary Completion: July 10, 2022
• Study Completion (Estimated): July 10, 2027
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)