Clinical trial NCT00824083: Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment
Official title: Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma, Ewing's
Keywords: bone tumors
long-term function
daily activity
late sequelae
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2009-01-16
Enrollment: 950
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ewing sarcoma survivors and 1:2 matched control group of healthy subjects

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: physical activity (SAM: step-activity-monitor)
timeFrame: 3-30years after primary diagnosis of Ewing sarcoma
Secondary outcomes:
measure: health-related quality of life (SF36, PEDQOL)
timeFrame: 3-30years after primary diagnosis of Ewing sarcoma
measure: functional status (TESS)
timeFrame: 3-30years after primary diagnosis of Ewing sarcoma
measure: psychological status (HADS, BIS-BAS)
timeFrame: 3-30years after primary diagnosis of Ewing sarcoma
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Pediatric Hematology and Oncology, University Children's Hospital
state: North Rhine Westphalia
city: Münster
country: Germany
facility: Motion Analysis Lab, Orthopedic Department, University Hospital
state: North Rhine Westphalia
Study officials:
affiliation: University Hospital Muenster
name: Andreas Ranft, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Muenster
name: Heribert Jürgens, Prof.
role: STUDY_CHAIR
References:
citation: Brandes M, Schomaker R, Mollenhoff G, Rosenbaum D. Quantity versus quality of gait and quality of life in patients with osteoarthritis. Gait Posture. 2008 Jul;28(1):74-9. doi: 10.1016/j.gaitpost.2007.10.004. Epub 2007 Nov 28.
citation: Gerber LH, Hoffman K, Chaudhry U, Augustine E, Parks R, Bernad M, Mackall C, Steinberg S, Mansky P. Functional outcomes and life satisfaction in long-term survivors of pediatric sarcomas. Arch Phys Med Rehabil. 2006 Dec;87(12):1611-7. doi: 10.1016/j.apmr.2006.08.341.
citation: Hoffmann C, Gosheger G, Gebert C, Jurgens H, Winkelmann W. Functional results and quality of life after treatment of pelvic sarcomas involving the acetabulum. J Bone Joint Surg Am. 2006 Mar;88(3):575-82. doi: 10.2106/JBJS.D.02488.
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citation: Nagarajan R, Neglia JP, Clohisy DR, Robison LL. Limb salvage and amputation in survivors of pediatric lower-extremity bone tumors: what are the long-term implications? J Clin Oncol. 2002 Nov 15;20(22):4493-501. doi: 10.1200/JCO.2002.09.006.
citation: Paulussen M, Craft AW, Lewis I, Hackshaw A, Douglas C, Dunst J, Schuck A, Winkelmann W, Kohler G, Poremba C, Zoubek A, Ladenstein R, van den Berg H, Hunold A, Cassoni A, Spooner D, Grimer R, Whelan J, McTiernan A, Jurgens H; European Intergroup Cooperative Ewing's Sarcoma Study-92. Results of the EICESS-92 Study: two randomized trials of Ewing's sarcoma treatment--cyclophosphamide compared with ifosfamide in standard-risk patients and assessment of benefit of etoposide added to standard treatment in high-risk patients. J Clin Oncol. 2008 Sep 20;26(27):4385-93. doi: 10.1200/JCO.2008.16.5720.
citation: Pieper S, Ranft A, Braun-Munzinger G, Jurgens H, Paulussen M, Dirksen U. Ewing's tumors over the age of 40: a retrospective analysis of 47 patients treated according to the International Clinical Trials EICESS 92 and EURO-E.W.I.N.G. 99. Onkologie. 2008 Dec;31(12):657-63. doi: 10.1159/000165361. Epub 2008 Nov 20.
citation: Rodl RW, Hoffmann C, Gosheger G, Leidinger B, Jurgens H, Winkelmann W. Ewing's sarcoma of the pelvis: combined surgery and radiotherapy treatment. J Surg Oncol. 2003 Jul;83(3):154-60. doi: 10.1002/jso.10256.
citation: Rosenbaum D, Brandes M, Hardes J, Gosheger G, Rodl R. Physical activity levels after limb salvage surgery are not related to clinical scores-objective activity assessment in 22 patients after malignant bone tumor treatment with modular prostheses. J Surg Oncol. 2008 Aug 1;98(2):97-100. doi: 10.1002/jso.21091.
citation: Schuck A, Ahrens S, Paulussen M, Kuhlen M, Konemann S, Rube C, Winkelmann W, Kotz R, Dunst J, Willich N, Jurgens H. Local therapy in localized Ewing tumors: results of 1058 patients treated in the CESS 81, CESS 86, and EICESS 92 trials. Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):168-77. doi: 10.1016/s0360-3016(02)03797-5.
citation: Song KM, Bjornson KF, Cappello T, Coleman K. Use of the StepWatch activity monitor for characterization of normal activity levels of children. J Pediatr Orthop. 2006 Mar-Apr;26(2):245-9. doi: 10.1097/01.bpo.0000218532.66856.6c.
citation: Weddington WW. Psychological outcomes in survivors of extremity sarcomas following amputation or limb-sparing surgery. Cancer Treat Res. 1991;56:53-60. doi: 10.1007/978-1-4615-3896-7_5. No abstract available.