Quality of LifeESOCARENCT03712774
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer
An observational study of Quality of Life and Chemoradiation, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Chemoradiation, Esophageal Cancer
- What is being tested?
- EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 12 Oct 2018to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: see eligibility criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, University Hospital, LMU Munich
Munich, Bavaria, 81377
Falk Roeder, MD, +49 89 4400 73729, Falk.Roeder@med.uni-muenchen.de
Franziska Walter, MD, +49 89 4400 73770, Franziska.Walter@med.uni-muenchen.de
About this study
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.
- Conditions
- Quality of Life, Chemoradiation, Esophageal Cancer
- Being tested
- EORTC QLQ C30, EORTC QLQ OES-18, EORTC OG-25
- Keywords
- quality of life, neoadjuvant, definitive, chemoradiation, esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ C30Other
standardized questionaire
EORTC QLQ OES-18Other
standardized questionaire
EORTC OG-25Other
standardized questionaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: EORTC QLQ C30; Other: EORTC QLQ OES-18; Other: EORTC OG-25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life measured by standardized EORTC questionaires
Measured: 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 (6)
Local control
Absence of local progression
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start12 Oct 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Falk Roeder, Ludwig-Maximilians - University of Munich
- Investigators
- Falk Roeder, MD, Principal investigator, Ludwig-Maximilians Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712774
- Sponsor's protocol ID
- V1 08_2018
- Acronym
- ESOCARE
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No