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

Recruiting

• Conditions: Chemoradiation; Esophageal Cancer; Quality of Life
• Interventions: Other: EORTC QLQ C30; Other: EORTC QLQ OES-18; Other: EORTC OG-25

• Registration Number: NCT03712774
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

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 Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-12
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Last Update Submitted: 2018-10-18
• Study First Posted: 2018-10-19
• Last Update Posted: 2018-10-19
• Primary Completion: 2021-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
definitive chemoradiation	EORTC OG-25	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
neoadjuvant chemoradiation	EORTC OG-25	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	EORTC QLQ OES-18	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
neoadjuvant chemoradiation	EORTC QLQ C30	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	EORTC QLQ C30	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
neoadjuvant chemoradiation	EORTC QLQ OES-18	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

Primary Outcome Measures

Name	Time	Method
Quality of life	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	Quality of life measured by standardized EORTC questionaires

Secondary Outcome Measures

Name	Time	Method
Distant Control	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	Absence of distant metastases
acute toxicity	end of RT, 6 weeks after end of RT, 3 months after end of RT	acute toxicity scored according to CTCAE 4.03
Local control	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	Absence of local progression
late toxicity	6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT	late toxicity scored according to CTCAE 4.03
freedom from treatment 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	Absence of local and distant failure
Overall survival	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	Absence of death by any cause

Trial Locations

Locations (1)

Department of Radiation Oncology, University Hospital, LMU Munich; 🇩🇪 Munich, Bavaria, Germany