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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Falk Roeder, MD contact

+49 89 4400 ext. 73729

Falk.Roeder@t-online.de

Franziska Walter, MD contact

+49 89 4400 ext. 73770

Franziska.Walter@med.uni-muenchen.de

Germany1 site, 1 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

    Recruiting

Other trials in Germany

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.

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 groups in NCT03712774
Study groupRoleWhat they receive
neoadjuvant chemoradiationPatient 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 chemoradiationPatient 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted19 Oct 2018
  2. Study start12 Oct 2018
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Chemoradiation, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Falk Roeder, MD (+49 89 4400 ext. 73729, Falk.Roeder@t-online.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03712774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.

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