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

Quality of Life Clinical Trial

— ESOCARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03712774
• Other study ID #: V1 08_2018
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Chemoradiation
• Esophageal Cancer
• Esophageal Neoplasms
• Quality of Life

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