A Phase 3 interventional study of dactinomycin and filgrastim in Sarcoma, sponsored by Children's Oncology Group. Completed at 233 sites in 7 countries. Open to participants aged Up to 49 Years. Per ClinicalTrials.gov, last updated 2014-02-14.
Sponsored by Children's Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.
PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.
OBJECTIVES:
OUTLINE: Patients are assigned to 1 of 2 groups, depending on histology and site of disease.
Patients are followed every 3-4 months for 3 years (4 years after diagnosis), every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 254 patients for group I will be accrued for this study within 6 years. Approximately 12 patients per year will be accrued for group II.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 483 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed embryonal (EMB) rhabdomyosarcoma (RMS) or botryoid or spindle cell variants of EMB RMS or embryonal ectomesenchymoma meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Failure-free survival
Showing the first 100 of 233 sites across 7 countries.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group