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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03253536

Studienbeginn:
Juli 2017

Letztes Update:
18.08.2017

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Hepatocellular, Liver Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ludwig-Maximilians - University of Munich

Collaborator:
-

Studienleiter

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

Kontakt

Falk Roeder, MD
Kontakt:
Phone: +49 89 4400 73729
E-Mail: Falk.Roeder@med.uni-muenchen.de» Kontaktdaten anzeigen

Sabine Gerum, MD
Kontakt:
Phone: +49 89 4400 73729
E-Mail: Sabine.Gerum@med.uni-muenchen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiation Oncology, University Hospital, LMU Munich
81377 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Falk Roeder, MD
Phone: +49 89 4400 73729
E-Mail: Falk.Roeder@med.uni-muenchen.de

Sabine Gerum, MD
Phone: +49 89 4400 73729
E-Mail: Sabine.Gerum@med.uni-muenchen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Quality of life (Time Frame - 60 months):
Quality of life

Secondary outcome:

1. acute toxicity (Time Frame - 3 months):
physician-related acute toxicity

2. late toxicity (Time Frame - 6, 12, 24, 36, 48, 60 months):
physician-related late toxicity

3. response (Time Frame - 3 months):
response to treatment according to imaging

4. local control (Time Frame - 60 months):
absence of regrowth inside the treated lesion

5. hepatic control (Time Frame - 60 months):
absence of regrowth or onset of new lesions inside the liver

6. distant control (Time Frame - 60 months):
absence of extrahepatic progression

7. freedom from treatment failure (Time Frame - 60 months):
absence of disease progression other than death

8. overall survival (Time Frame - 60 months):
absence of death of any cause

9. pattern of recurrence (Time Frame - 60 months):
pattern of recurrence

10. correlation Qol with acute toxicity (Time Frame - 3 months):
correlation Qol with acute toxicity

11. correlation Qol with late toxicity (Time Frame - 6, 12, 24, 36, 48, 60 months):
correlation Qol with late toxicity

Geprüfte Regime

observational:
none (observational study)

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!