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RecruitingNCT03712774ESOCAREUpdated Oct 19, 2018

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

An observational study in Quality of Life, Chemoradiation and Esophageal Cancer, sponsored by Ludwig-Maximilians - University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-19.

Sponsored by Ludwig-Maximilians - University of Munich · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2021, 4 years 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2018; still recruiting 7 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Quality of Life
  • Chemoradiation
  • Esophageal Cancer

Keywords

  • quality of life
  • neoadjuvant
  • definitive
  • chemoradiation
  • esophageal cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

see eligibility criteria

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 · Other: EORTC QLQ OES-18 · Other: 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

    Other: EORTC QLQ C30 · Other: EORTC QLQ OES-18 · Other: EORTC OG-25

Interventions

  • OtherEORTC QLQ C30

    standardized questionaire

  • OtherEORTC QLQ OES-18

    standardized questionaire

  • OtherEORTC OG-25

    standardized questionaire

06

What researchers measure

Primary outcomes

  1. Quality of life

    Quality of life measured by standardized EORTC questionaires

    Time frame: 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 outcomes

  1. Local control

    Absence of local progression

    Time frame: 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

  2. Distant Control

    Absence of distant metastases

    Time frame: 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

  3. freedom from treatment failure

    Absence of local and distant failure

    Time frame: 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

  4. Overall survival

    Absence of death by any cause

    Time frame: 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

  5. acute toxicity

    acute toxicity scored according to CTCAE 4.03

    Time frame: end of RT, 6 weeks after end of RT, 3 months after end of RT

  6. late toxicity

    late toxicity scored according to CTCAE 4.03

    Time frame: 6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT

07

Study locations

1 of 1 sites recruiting
  • Department of Radiation Oncology, University Hospital, LMU Munich
    Munich, Bavaria 81377, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03712774
Lead sponsor
Ludwig-Maximilians - University of Munich
Responsible party
Falk Roeder (Consultant, Ludwig-Maximilians - University of Munich) — Principal investigator
First posted
Oct 19, 2018
Start date
Oct 12, 2018
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 19, 2018

Study contacts

Falk Roeder, MD
Contact
Falk.Roeder@t-online.de
+49 89 4400 ext. 73729
Franziska Walter, MD
Contact
Franziska.Walter@med.uni-muenchen.de
+49 89 4400 ext. 73770
Falk Roeder, MD
principal investigator · Ludwig-Maximilians Universität München

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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