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

NCT ID: NCT03712774

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-12

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Quality of Life Chemoradiation Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

EORTC QLQ C30

Intervention Type OTHER

standardized questionaire

EORTC QLQ OES-18

Intervention Type OTHER

standardized questionaire

EORTC OG-25

Intervention Type OTHER

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

EORTC QLQ C30

Intervention Type OTHER

standardized questionaire

EORTC QLQ OES-18

Intervention Type OTHER

standardized questionaire

EORTC OG-25

Intervention Type OTHER

standardized questionaire

Interventions

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EORTC QLQ C30

standardized questionaire

Intervention Type OTHER

EORTC QLQ OES-18

standardized questionaire

Intervention Type OTHER

EORTC OG-25

standardized questionaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Falk Roeder

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Falk Roeder, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians Universität München

Locations

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Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Falk Roeder, MD

Role: CONTACT

+49 89 4400 ext. 73729

Franziska Walter, MD

Role: CONTACT

+49 89 4400 ext. 73770

Facility Contacts

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Falk Roeder, MD

Role: primary

+49 89 4400 73729

Franziska Walter, MD

Role: backup

+49 89 4400 73770

Other Identifiers

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V1 08_2018

Identifier Type: -

Identifier Source: org_study_id

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