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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-10

Study Completion Date

2027-07-10

Brief Summary

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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.

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Detailed Description

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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

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Hepatocellular Cancer Quality of Life Stereotactic Body Radiation Therapy Observational

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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entire cohort

none (observational study)

observational

Intervention Type OTHER

none (observational study)

Interventions

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observational

none (observational study)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No