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Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

6 Years
60 Years
Open (Enrolling)
Sarcoma, Ewing's

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Trial Information

Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

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 1100 long-term Ewing sarcoma
survivors and a control group of 1100 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.

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

- <5y after diagnosis

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

real-world daily activity (SAM: step-activity-monitor)

Outcome Time Frame:

5-30years after primary diagnosis of Ewing sarcoma

Safety Issue:


Principal Investigator

Heribert J├╝rgens, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Muenster


Germany: Ethics Commission

Study ID:




Start Date:

July 2009

Completion Date:

July 2014

Related Keywords:

  • Sarcoma, Ewing's
  • bone tumors
  • long-term function
  • daily activity
  • late sequelae
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma