Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarc

Trial Details

NCT ID
NCT05304585
Phase
PHASE3
Sponsor
Children's Oncology Group
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Biopsy Procedure
  • Bone Scan
  • Computed Tomography
  • Cyclophosphamide
  • Dactinomycin
  • Magnetic Resonance Elastography
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Downey, California, United States|33.94001,-118.13257

Key Eligibility Criteria

  • All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and…
  • Patients must be =\< 21 years at the time of enrollment.
  • Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarco…
  • All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remai…

For full eligibility, visit ClinicalTrials.gov.

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