NCT00339898|Completed
Prognostic Value of a Positive RT-PCR Test in Patients With Ewing Sarcoma
Prospective Evaluation of the Prognostic Relevance of PCR Positivity in Blood and Bone Marrow in Non-Metastatic Ewings Sarcoma
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Prospective Evaluation of the Prognostic Relevance of PCR Positivity in Blood and Bone Marrow in Non-Metastatic Ewings Sarcoma
Sponsor study identifier
Secondary identifiers
observational
414
1 country
1
Study Start
March 12, 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 13, 2015
Date type not reportedThis date has not been verified as actual or estimated.
This study will determine whether the results of a test called reverse transcriptase-polymerase chain reaction (RT-PCR) correlate with clinical outcomes in patients with Ewing sarcoma, and if they can be used to help identify patients at high risk for metastasis (spread of the cancer beyond the original site). This is a companion study to another NCI trial (AEWS0031), which is examining the effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma. The primary purposes of AEWS0031 are to determine: 1) if chemotherapy given every 2 weeks can cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3 weeks; and 2) if certain biological characteristics of these tumors can predict how well the chemotherapy will work. Many, but not all, patients with Ewing sarcoma that has not metastasized can be cured with standard radiation, surgery, and chemotherapy treatment. Most patients whose tumors have spread, however, are not cured with standard treatment. A goal of future therapy is to identify patients at highest risk for metastasis so that they can be given more intensive therapy, and, conversely, patients at lower risk of relapse can receive less toxic treatment. Patients enrolled in AEWS0031 are eligible for this companion study. No additional procedures re required; RT-PCR testing will be performed on blood and bone marrow samples collected for AEWS0031. ...
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 13, 2015
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2004
Date type not reportedThis date has not been verified as actual or estimated.
June 19, 2006
Actual (reported)June 21, 2006
Actual (reported)January 13, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Grier HE, Krailo MD, Tarbell NJ, Link MP, Fryer CJ, Pritchard DJ, Gebhardt MC, Dickman PS, Perlman EJ, Meyers PA, Donaldson SS, Moore S, Rausen AR, Vietti TJ, Miser JS. Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone. N Engl J Med. 2003 Feb 20;348(8):694-701. doi: 10.1056/NEJMoa020890.
West DC, Grier HE, Swallow MM, Demetri GD, Granowetter L, Sklar J. Detection of circulating tumor cells in patients with Ewing's sarcoma and peripheral primitive neuroectodermal tumor. J Clin Oncol. 1997 Feb;15(2):583-8. doi: 10.1200/JCO.1997.15.2.583.
Crystal L Mackall, M.D.
National Cancer Institute (NCI)
414 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
March 12, 2004
Date type not reportedThis date has not been verified as actual or estimated.
Pfleiderer C, Zoubek A, Gruber B, Kronberger M, Ambros PF, Lion T, Fink FM, Gadner H, Kovar H. Detection of tumour cells in peripheral blood and bone marrow from Ewing tumour patients by RT-PCR. Int J Cancer. 1995 Apr 21;64(2):135-9. doi: 10.1002/ijc.2910640211.
Study Completion
January 13, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
December 17, 2019
Record last verified: 2015-01-13
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