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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.

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.

Eligibility

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

Study details
    Quality of Life
    Chemoradiation
    Esophageal Cancer

NCT03712774

Ludwig-Maximilians - University of Munich

27 January 2024

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