A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)

This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of a

Trial Details

NCT ID
NCT07466316
Phase
PHASE3
Sponsor
Children's Oncology Group
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Bone Scan
  • Computed Tomography
  • Cyclophosphamide
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Duarte, California, United States|34.13945,-117.97729
  • Loma Linda, California, United States|34.04835,-117.26115

Key Eligibility Criteria

  • Patient must be ≤ 50 years of age at the time of enrollment
  • Patients with newly diagnosed soft tissue RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classificatio…
  • FOXO1 fusion negative (FN)
  • Stage 2/3, Group III

For full eligibility, visit ClinicalTrials.gov.

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