Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

Sarcoma, Ewing's Clinical Trial

Official title:

Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824083
• Other study ID #: 01ER0807
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: April 27, 2016
• Start date: July 2009
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Ewing
• Sarcoma, Ewing's

Locations

Country	Name	City	State
Germany	Department of Pediatric Hematology and Oncology, University Children's Hospital	Muenster	North Rhine Westphalia
Germany	Motion Analysis Lab, Orthopedic Department, University Hospital	Münster	North Rhine Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (12)

Brandes M, Schomaker R, Möllenhoff G, Rosenbaum D. Quantity versus quality of gait and quality of life in patients with osteoarthritis. Gait Posture. 2008 Jul;28(1):74-9. Epub 2007 Nov 28. — View 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. — View Citation

Hoffmann C, Gosheger G, Gebert C, Jürgens 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. — View Citation

McDonald CM, Widman L, Abresch RT, Walsh SA, Walsh DD. Utility of a step activity monitor for the measurement of daily ambulatory activity in children. Arch Phys Med Rehabil. 2005 Apr;86(4):793-801. — View 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. Review. — View Citation

Paulussen M, Craft AW, Lewis I, Hackshaw A, Douglas C, Dunst J, Schuck A, Winkelmann W, Köhler G, Poremba C, Zoubek A, Ladenstein R, van den Berg H, Hunold A, Cassoni A, Spooner D, Grimer R, Whelan J, McTiernan A, Jürgens 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. — View 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. — View Citation

Rödl RW, Hoffmann C, Gosheger G, Leidinger B, Jürgens H, Winkelmann W. Ewing's sarcoma of the pelvis: combined surgery and radiotherapy treatment. J Surg Oncol. 2003 Jul;83(3):154-60. — View Citation

Rosenbaum D, Brandes M, Hardes J, Gosheger G, Rödl 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. — View Citation

Schuck A, Ahrens S, Paulussen M, Kuhlen M, Könemann S, Rübe C, Winkelmann W, Kotz R, Dunst J, Willich N, Jürgens 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. — View 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. — View Citation

Weddington WW. Psychological outcomes in survivors of extremity sarcomas following amputation or limb-sparing surgery. Cancer Treat Res. 1991;56:53-60. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity (SAM: step-activity-monitor)		3-30years after primary diagnosis of Ewing sarcoma	No
Secondary	health-related quality of life (SF36, PEDQOL)		3-30years after primary diagnosis of Ewing sarcoma	No
Secondary	functional status (TESS)		3-30years after primary diagnosis of Ewing sarcoma	No
Secondary	psychological status (HADS, BIS-BAS)		3-30years after primary diagnosis of Ewing sarcoma	No