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

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ClinicalTrials.gov Identifier: NCT03712774
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Falk Roeder, 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.

Condition or disease Intervention/treatment
Quality of Life Chemoradiation Esophageal Cancer 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]
    Quality of life measured by standardized EORTC questionaires


Secondary Outcome Measures :
  1. Local control [ 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 ]
    Absence of local progression

  2. Distant Control [ 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 ]
    Absence of distant metastases

  3. freedom from treatment 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 ]
    Absence of local and distant failure

  4. Overall survival [ 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 ]
    Absence of death by any cause

  5. acute toxicity [ Time Frame: end of RT, 6 weeks after end of RT, 3 months after end of RT ]
    acute toxicity scored according to CTCAE 4.03

  6. late toxicity [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
see eligibility criteria
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712774


Contacts
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Contact: Falk Roeder, MD +49 89 4400 ext 73729 Falk.Roeder@t-online.de
Contact: Franziska Walter, MD +49 89 4400 ext 73770 Franziska.Walter@med.uni-muenchen.de

Locations
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Germany
Department of Radiation Oncology, University Hospital, LMU Munich Recruiting
Munich, Bavaria, Germany, 81377
Contact: Falk Roeder, MD    +49 89 4400 73729    Falk.Roeder@med.uni-muenchen.de   
Contact: Franziska Walter, MD    +49 89 4400 73770    Franziska.Walter@med.uni-muenchen.de   
Sub-Investigator: Sabine Gerum, MD         
Sub-Investigator: Michael Hoffmann, MD         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: Falk Roeder, MD Ludwig-Maximilians Universität München

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Responsible Party: Falk Roeder, Consultant, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT03712774     History of Changes
Other Study ID Numbers: V1 08_2018
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Falk Roeder, Ludwig-Maximilians - University of Munich:
quality of life
neoadjuvant
definitive
chemoradiation
esophageal cancer

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases