Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EORTC QLQ C30, EORTC QLQ OES-18, EORTC OG-25.
- Who it may be relevant to
- Registry conditions: Quality of Life, Chemoradiation, Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- Other EORTC QLQ C30
standardized questionaire - Other EORTC QLQ OES-18
standardized questionaire - Other EORTC OG-25
standardized questionaire
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
- 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]
- 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]
- 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]
- acute toxicity [Time frame: end of RT, 6 weeks after end of RT, 3 months after end of RT]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Radiation Oncology, University Hospital, LMU Munich — Munich
Identifiers
NCT: NCT03712774 · V1 08_2018