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drugset / Trial / NCT00354744

High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma

NCT00354744 ↗

Phase 3 Completed 109 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.

Timeline

Start
2006-07
Primary completion
2010-01
Completion
2019-06-30

Publications

  • Results Weigel B, Lyden E, Anderson JR, et al.: Early results from Children's Oncology Group (COG) ARST0431: intensive multidrug therapy for patients with metastatic rhabdomyosarcoma (RMS). [Abstract] J Clin Oncol 28 (Suppl 15): A-9503, 2010.

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 40 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 1200 mg/m2 Intravenous
Subject Dactinomycin Protein / enzyme biologic 0.025 mg/kg Intravenous
Subject Dactinomycin Protein / enzyme biologic 0.045 mg/kg Intravenous
Subject Doxorubicin Other / unclassified 37.5 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Ifosfamide Small molecule 1800 mg/m2 Intravenous
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Vincristine Small molecule 0.025 mg/kg Intravenous
Subject Vincristine Small molecule 0.05 mg/kg Intravenous
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications

sarcoma