Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03792854

Studienbeginn:
Dezember 2018

Letztes Update:
03.01.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Anus Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ludwig-Maximilians - University of Munich

Collaborator:
-

Studienleiter

Falk Roeder, MD
Principal Investigator
Ludwig-Maximilians Universität München

Kontakt

Falk Roeder, MD
Kontakt:
Phone: +49894400
Phone (ext.): 73729
E-Mail: falk.roeder@t-online.de» Kontaktdaten anzeigen

Sabine Gerum, MD
Kontakt:
Phone: +49894400
Phone (ext.): 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: +49894400
Phone (ext.): 73729
E-Mail: Falk.Roeder@med.uni-muenchen.de

Sabine Gerum, MD
Phone: +49894400
Phone (ext.): 73729
E-Mail: sabine.gerum@med.uni-muenchen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Observational study to evaluate longitudinal quality of life according to standardized EORTC

questionaires as well as functional outcome, oncological outcome and toxicity in patients

treated with definitive chemoradiation for anal cancer. Qol will be evaluated by standardized

EORTC questionaires QLQ C30 and QLQ CR29. Acute and late toxicity will be assessed according

to CTCAE 4.03. Oncological outcome will be assessed with regard to local and distant control,

patterns of recurrence, freedom from treatment failure and overall survival. Correlations of

physicians- and patients-assessed functional outcomes are planned.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- histologically proven anal cancer without distant metastases

- indication for definitive chemoradiation therapy based on multidisciplinary evaluation

- age >=18 years

- written informed consent

- ability to answer the standardized questionaires according to the treating physician

Exclusion Criteria:

- age < 18 years

- prior systemic therapy with regard to anal cancer

- distant metastases

- second malignancy

Studien-Rationale

Primary outcome:

1. Qol (EORTC QLQC30) absolute values and change over time (Time Frame - day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266):
Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time

2. Qol (EORTC QLQCR29) absolute values and change over time (Time Frame - day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266):
Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time

Secondary outcome:

1. local control (Time Frame - end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266):
absence of disease progression inside the target volume of radiation therapy

2. distant control (Time Frame - end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266):
absence of disease progression outside the target volume of radiation therapy

3. freedom from treatment failure (Time Frame - end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266):
absence of disease progression inside or outside the target volume of radiation therapy

4. overall survival (Time Frame - end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266):
absence of death from any cause

5. acute toxicity (Time Frame - day 0, end of week 6, 12, 19):
acute toxicity caused by chemoradiation according to CTCAE 4.03

6. late toxicity (Time Frame - end of week 32, 58, 84, 110, 162, 214, 266):
late toxicity caused by chemoradiation according to CTCAE 4.03

Geprüfte Regime

EORTC QLQ C30:
standardized questionaire
EORTC QLQ CR29:
standardized questionaire

Quelle: ClinicalTrials.gov

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