Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03712774

Studienbeginn:
Oktober 2018

Letztes Update:
19.10.2018

Wirkstoff:
-

Indikation (Clinical Trials):
Esophageal 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: +49 89 4400
Phone (ext.): 73729
E-Mail: Falk.Roeder@t-online.de» Kontaktdaten anzeigen

Franziska Walter, MD
Kontakt:
Phone: +49 89 4400
Phone (ext.): 73770
E-Mail: Franziska.Walter@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

Franziska Walter, MD
Phone: +49 89 4400 73770
E-Mail: Franziska.Walter@med.uni-muenchen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Prospective observational study to evaluate the Quality of life based in patients treated

with neoadjuvant or definitive chemoradiation for esophageal Cancer. QoL will be evaluated by

standardized EORTC questionaires. Acute and late toxicity will be assessed according to CTCAE

4.03. Outcome measures will include local Control, distant Control, freedom from Treatment

failure and overall survival. Correlations are planned between Patient- and

physician-assessed functional Outcome.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- histologically proven esophageal Cancer (SCC or adenocarcinoma) without distant

metastases (except supraclavicular nodes)

- indication for neoadjuvant or definitive chemoradiation using either cisplatin/5-FU or

carboplatin/paclitaxel with curative intent

- age >= 18 years

- written informed consent

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

Exclusion Criteria:

- age < 18 years

- Treatment with palliative intent

- distant metastases (except supraclavicular nodes)

- second malignancy

- Prior systemic treatment for esophageal Cancer

- Treatment in an interventional study

Studien-Rationale

Primary outcome:

1. Quality of life (Time Frame - planning CT (day 0), week 4 of RT, 6 weeks after end of RT, 3 months after end of RT, 6 months after end of RT, 12 months after end of RT, 24, 36, 48, and 60 months after end of RT):
Quality of life measured by standardized EORTC questionaires

Secondary outcome:

1. Local control (Time Frame - 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT):
Absence of local progression

2. Distant Control (Time Frame - 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT):
Absence of distant metastases

3. freedom from treatment failure (Time Frame - 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT):
Absence of local and distant failure

4. Overall survival (Time Frame - 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT):
Absence of death by any cause

5. acute toxicity (Time Frame - end of RT, 6 weeks after end of RT, 3 months after end of RT):
acute toxicity scored according to CTCAE 4.03

6. late toxicity (Time Frame - 6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT):
late toxicity scored according to CTCAE 4.03

Studien-Arme

neoadjuvant chemoradiation
Patient with esophageal Cancer treated by neoadjuvant chemoradiation followed by surgery will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25
definitive chemoradiation
Patient with esophageal Cancer treated by definitive chemoradiation will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25

Geprüfte Regime

EORTC QLQ C30:
standardized questionaire
EORTC QLQ OES-18:
standardized questionaire
EORTC OG-25:
standardized questionaire

Quelle: ClinicalTrials.gov

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