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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Quality of Life, Chemoradiation, Esophageal Cancer

Intervention / Treatment
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* Other: EORTC QLQ C30
* Other: EORTC QLQ OES-18
* Other: EORTC OG-25


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neoadjuvant chemoradiation<br>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 | Other: EORTC QLQ C30<br>* standardized questionaire<br>Other: EORTC QLQ OES-18<br>* standardized questionaire<br>Other: EORTC OG-25<br>* standardized questionaire<br>|
| definitive chemoradiation<br>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 | Other: EORTC QLQ C30<br>* standardized questionaire<br>Other: EORTC QLQ OES-18<br>* standardized questionaire<br>Other: EORTC OG-25<br>* standardized questionaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life measured by standardized EORTC questionaires | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | Absence of local progression | 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 | Absence of distant metastases | 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 | Absence of local and distant failure | 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 | Absence of death by any cause | 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 | acute toxicity scored according to CTCAE 4.03 | end of RT, 6 weeks after end of RT, 3 months after end of RT | 
| late toxicity | late toxicity scored according to CTCAE 4.03 | 6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, neoadjuvant, definitive, chemoradiation, esophageal cancer