Chemoradiation, Esophageal Cancer, Quality of Life
Conditions
Keywords
quality of life, neoadjuvant, definitive, chemoradiation, esophageal cancer
Brief summary
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
OTHEREORTC QLQ C30
standardized questionaire
OTHEREORTC QLQ OES-18
standardized questionaire
OTHEREORTC OG-25
standardized questionaire
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Distant Control | 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 |
| freedom from treatment 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 | Absence of local and distant failure |
| Local control | 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 |
| acute toxicity | end of RT, 6 weeks after end of RT, 3 months after end of RT | acute toxicity scored according to CTCAE 4.03 |
| late toxicity | 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 |
| Overall survival | 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 |
Countries
Germany
Contacts
Primary ContactFalk Roeder, MD
Backup ContactFranziska Walter, MD
Outcome results
None listed