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

• Sponsor: Ludwig-Maximilians - University of Munich (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03253536
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Cancer; Quality of Life; Stereotactic Body Radiation Therapy; Observational	Other: observational

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
• Actual Study Start Date: Jul 10, 2017
• Anticipated Primary Completion Date: Jul 10, 2022
• Anticipated Study Completion Date: Jul 10, 2027

Arms and Interventions

Arm	Intervention/Treatment
entire cohort none (observational study)	Other: observational; none (observational study)

Outcome Measures

Primary Outcome Measures

1. Quality of life [60 months]

   Quality of life

Secondary Outcome Measures

1. acute toxicity [3 months]

   physician-related acute toxicity

2. late toxicity [6, 12, 24, 36, 48, 60 months]

   physician-related late toxicity

3. response [3 months]

   response to treatment according to imaging

4. local control [60 months]

   absence of regrowth inside the treated lesion

5. hepatic control [60 months]

   absence of regrowth or onset of new lesions inside the liver

6. distant control [60 months]

   absence of extrahepatic progression

7. freedom from treatment failure [60 months]

   absence of disease progression other than death

8. overall survival [60 months]

   absence of death of any cause

9. pattern of recurrence [60 months]

   pattern of recurrence

10. correlation Qol with acute toxicity [3 months]

    correlation Qol with acute toxicity

11. correlation Qol with late toxicity [6, 12, 24, 36, 48, 60 months]

    correlation Qol with late toxicity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiation Oncology, University Hospital, LMU Munich	Munich	Bavaria	Germany	81377

Sponsors and Collaborators

• Ludwig-Maximilians - University of Munich

Investigators

• Principal Investigator: Falk Roeder, MD, Department of Radiation Oncology, University Hospital, LMU Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Falk Roeder, Consultant Radiation Oncology, Ludwig-Maximilians - University of Munich
• ClinicalTrials.gov Identifier: NCT03253536
• Other Study ID Numbers: Livercare
• First Posted: Aug 18, 2017
• Last Update Posted: Aug 18, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Falk Roeder, Consultant Radiation Oncology, Ludwig-Maximilians - University of Munich: Hepatocellular Cancer; Quality of Life; stereotactic body radiation therapy; observational
• Additional relevant MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms

Study Results

No Results Posted as of Aug 18, 2017