NCT00824083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

6 years

First QC Date

January 15, 2009

Last Update Submit

April 27, 2016

Conditions

Sarcoma, Ewing's

Keywords

bone tumorslong-term functiondaily activitylate sequelae

Outcome Measures

Primary Outcomes (1)

  • physical activity (SAM: step-activity-monitor)

    3-30years after primary diagnosis of Ewing sarcoma

Secondary Outcomes (3)

  • health-related quality of life (SF36, PEDQOL)

    3-30years after primary diagnosis of Ewing sarcoma

  • functional status (TESS)

    3-30years after primary diagnosis of Ewing sarcoma

  • psychological status (HADS, BIS-BAS)

    3-30years after primary diagnosis of Ewing sarcoma

Study Arms (2)

1

sarcoma survivors

2

healthy subjects

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatric Hematology and Oncology, University Children's Hospital

Münster, North Rhine-Westphalia, 48129, Germany

Location

Motion Analysis Lab, Orthopedic Department, University Hospital

Münster, North Rhine-Westphalia, 48129, Germany

Location

Related Publications (12)

  • 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.

    PMID: 18054233BACKGROUND

  • 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.

    PMID: 17141641BACKGROUND

  • 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.

    PMID: 16510825BACKGROUND

  • 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. doi: 10.1016/j.apmr.2004.10.011.

    PMID: 15827934BACKGROUND

  • 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.

    PMID: 12431974BACKGROUND

  • 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.

    PMID: 18802150BACKGROUND

  • 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.

    PMID: 19060503BACKGROUND

  • 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.

    PMID: 12827683BACKGROUND

  • 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.

    PMID: 18521841BACKGROUND

  • 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.

    PMID: 12504050BACKGROUND

  • 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.

    PMID: 16557143BACKGROUND

  • 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.

    PMID: 1681879BACKGROUND

MeSH Terms

Conditions

Sarcoma, EwingBone Neoplasms

Condition Hierarchy (Ancestors)

OsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Study Officials

  • Andreas Ranft, Dr.

    University Hospital Muenster

    PRINCIPAL INVESTIGATOR

  • Heribert Jürgens, Prof.

    University Hospital Muenster

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)