Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

April 27, 2016 updated by: University Hospital Muenster
The purpose of the study is to assess the functional outcome, quality of life and late sequelae in a representative sample of 600 long-term survivors of Ewing sarcoma and to build a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma patients with a follow-up of 3 decades.

Study Overview

Status

Completed

Conditions

Detailed Description

Trial objective: As survival rates of bone sarcoma patients have been raised owing to improved treatment strategies the focus of investigations is now on the medical, social, and economic sequelae of intensive multimodal treatment. This study aims to assess the functional outcome, quality of life and late sequelae in a representative sample of long-term survivors of Ewing sarcoma. The data recorded combined with standardized treatment data covering a 30-year period will produce a data pool that is unique for its magnitude and will be used for the development of guidelines for further improvements of future bone sarcoma treatment.

Working plan: The working plan provides for the assessment of functional outcome and quality of life by means of validated tools (TESS, SF36, PEDQOL) and objectively measuring daily activity patterns by using the Step Activity Monitor (SAM) in 600 long-term Ewing sarcoma survivors and a control group of 300 matched healthy subjects. Information on sarcoma treatment and follow-up is obtained by re-structuring and complementing the database of the relevant patient cohort (n=3000) from four consecutive nationwide and international clinical trials between 1980 and 2008. Procedures of local treatment will be evaluated regarding functional outcome, quality of life, and survival probability and prognostic factors predicting long-term outcome will be identified.

Exploitation of results: The results will be presented at scientific meetings and will be published in international journals. Guidelines will be developed regarding improvements in the treatment, rehabilitation, and social integration of bone sarcoma patients to be utilized in guiding patients and in the decision process of medical professionals regarding their treatment. In the long run, the evidence based guidelines on treatment and follow-up are to be transferred into the health system.

Study Type

Observational

Enrollment (Actual)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Rhine Westphalia
      • Muenster, North Rhine Westphalia, Germany, 48129
        • Department of Pediatric Hematology and Oncology, University Children's Hospital
      • Münster, North Rhine Westphalia, Germany, 48129
        • Motion Analysis Lab, Orthopedic Department, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ewing sarcoma survivors and 1:2 matched control group of healthy subjects

Description

Inclusion Criteria:

  • CESS81/CESS86/EICESS92/EURO-E.W.I.N.G.99 trials participants of the German Society of Pediatric Hematology and Oncology (GPOH)

Exclusion Criteria:

  • no complete remission (CR)
  • any kind of paralysis
  • <3y after diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
sarcoma survivors
2
healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
physical activity (SAM: step-activity-monitor)
Time Frame: 3-30years after primary diagnosis of Ewing sarcoma
3-30years after primary diagnosis of Ewing sarcoma

Secondary Outcome Measures

Outcome Measure
Time Frame
health-related quality of life (SF36, PEDQOL)
Time Frame: 3-30years after primary diagnosis of Ewing sarcoma
3-30years after primary diagnosis of Ewing sarcoma
functional status (TESS)
Time Frame: 3-30years after primary diagnosis of Ewing sarcoma
3-30years after primary diagnosis of Ewing sarcoma
psychological status (HADS, BIS-BAS)
Time Frame: 3-30years after primary diagnosis of Ewing sarcoma
3-30years after primary diagnosis of Ewing sarcoma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andreas Ranft, Dr., University Hospital Muenster
  • Study Chair: Heribert Jürgens, Prof., University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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