Quality of Life Clinical Trial
— ESOCAREOfficial title:
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Radiation Oncology, University Hospital, LMU Munich | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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