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)

Sponsor
Children's Oncology Group
Study ID
NCT07466316
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and cerebrospinal fluid sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Cyclophosphamide — DRUG
    Given IV and PO
  • Dactinomycin — BIOLOGICAL
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Lymph Node Biopsy — PROCEDURE
    Undergo lymph node biopsy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo FDG PET scan
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Resection — PROCEDURE
    Undergo resection surgery
  • Survey Administration — OTHER
    Ancillary studies
  • Vincristine Sulfate — DRUG
    Given IV
  • Vinorelbine Tartrate — DRUG
    Given IV

Study Details

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 antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.

Key Dates

Start date
Jun 22, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
342 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A (Higher cyclophosphamide dose regimen
    See Detailed Description for Regimen A.
  • Experimental: Regimen B (Lower cyclophosphamide dose, maintenance)
    See Detailed Description for Regimen B.

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: From randomization until the first occurrence of progression or relapse, second malignancy, or death, up to 5 years ]

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