Study Information
Summary / Purpose
To compare whether 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.
Study Type: Interventional
Accepts Healthy Volunteers: No
Who Can Participate
Eligibility Criteria: - Children and Adults 50 years of age and younger
- Newly diagnosed intermediate-risk rhabdomyosarcoma (RMS) of any subtype
- Care team will confirm the specific tumor type, stage, and genetic features (such as FOXO1 fusion status) to determine eligibility
- No prior treatment for RMS
- Cannot have adult-type pleomorphic RMS
What's Involved
Participation in the study will include: - Random assignment to one of two chemotherapy plans: a higher dose of chemotherapy given over a shorter period (Regimen A), or a lower dose given over a longer period followed by maintenance chemotherapy (Regimen B)
- Chemotherapy given through a vein in repeating cycles; the drugs depend on which plan you are assigned to
- Surgery to remove the tumor, if needed
- A lymph node biopsy, if needed
- Radiation therapy to the original tumor site and/or to sites where the cancer has spread
- Computed tomography (CT) scans and/or magnetic resonance imaging (MRI) scans
- Blood sample collection
- Fludeoxyglucose (FDG) positron emission tomography (PET) scans, bone scans, bone marrow biopsy and aspiration, and lumbar puncture to collect spinal fluid, if needed
- Completing surveys
Principal Investigator
Additional Information
Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.
