Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemoradiation | 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 |
| |
| definitive chemoradiation | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EORTC QLQ C30 | Other | standardized questionaire |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
see eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Falk Roeder, MD | Contact | +49 89 4400 | 73729 | Falk.Roeder@t-online.de |
| Franziska Walter, MD | Contact | +49 89 4400 | 73770 | Franziska.Walter@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Falk Roeder, MD | Ludwig-Maximilians Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, University Hospital, LMU Munich | Recruiting | Munich | Bavaria | 81377 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EORTC QLQ OES-18 | Other | standardized questionaire |
|
| EORTC OG-25 | Other | standardized questionaire |
|
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 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided