Non-Metastatic Ewings Sarcoma Clinical Trial
Official title:
Prospective Evaluation of the Prognostic Relevance of PCR Positivity in Blood and Bone Marrow in Non-Metastatic Ewings Sarcoma
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.
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BACKGROUND: Clinical evidence for metastatic disease at the time of diagnosis is an indicator
of poor prognosis in Ewing's sarcoma. Patients with non-metastatic disease at presentation
are thought to have a better prognosis than those with metastatic disease. Unfortunately,
patients who appear non-metastatic at presentation may relapse after initiating or completing
standard therapy for Ewing's sarcoma. Evidence of metastatic disease may be determined by
radiographic studies and biopsy of potential site(s) of disease. It is possible to identify
submicroscopic Ewing's sarcoma cells in blood and bone marrow, yet the prognostic value of
this finding is unclear.
OBJECTIVES: To determine the incidence of RT PCR positivity in the blood and bone marrow of
patients enrolled on COG AEWS0031 and to correlate the clinical outcome with RT PCR
positivity.
ELIGIBILITY: Concurrent enrollment on COG AEWS0031.
DESIGN: This is a Companion Biology Study, enrolling approximately 500 patients. All
specimens will be evaluated for translocations, it is anticipated that approximately 30% of
specimens will have RT PCR positivity. Specimens are collected at the time of diagnosis,
prior to cycle 2 chemotherapy, prior to initiation of local control, and at the end of
therapy/follow up. Batched specimens are provided to the NIH by the Cooperative Human Tissue
Network (CHTN). Following the completion of the COG trial and appropriate follow up periods,
RT PCR positivity will be compared with clinical outcome to determine prognostic value.
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