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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03712774
Other study ID # V1 08_2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 12, 2018
Est. completion date December 31, 2026

Study information

Verified date October 2018
Source Ludwig-Maximilians - University of Munich
Contact Falk Roeder, MD
Phone +49 89 4400
Email Falk.Roeder@t-online.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
EORTC QLQ C30
standardized questionaire
EORTC QLQ OES-18
standardized questionaire
EORTC OG-25
standardized questionaire

Locations

Country Name City State
Germany Department of Radiation Oncology, University Hospital, LMU Munich Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

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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