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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Esophageal Cancer; Chemoradiation
• Intervention / Treatment: Other: EORTC QLQ C30; Other: EORTC QLQ OES-18; Other: EORTC OG-25

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Falk Roeder, MD; Phone Number: 73729 +49 89 4400; Email: Falk.Roeder@t-online.de
• Study Contact Backup: Name: Franziska Walter, MD; Phone Number: 73770 +49 89 4400; Email: Franziska.Walter@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Department of Radiation Oncology, University Hospital, LMU Munich
      • Sub-Investigator: Michael Hoffmann, MD
      • Contact: Falk Roeder, MD; Phone Number: +49 89 4400 73729; Email: Falk.Roeder@med.uni-muenchen.de
      • Contact: Franziska Walter, MD; Phone Number: +49 89 4400 73770; Email: Franziska.Walter@med.uni-muenchen.de
      • Sub-Investigator: Sabine Gerum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

see eligibility criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: EORTC QLQ C30; standardized questionaire; Other: EORTC QLQ OES-18; standardized questionaire; Other: EORTC OG-25; standardized questionaire
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	Other: EORTC QLQ C30; standardized questionaire; Other: EORTC QLQ OES-18; standardized questionaire; Other: EORTC OG-25; standardized questionaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Falk Roeder, MD, Ludwig-Maximilians Universitat Munchen

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: neoadjuvant; quality of life; esophageal cancer; chemoradiation; definitive
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: V1 08_2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No