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

Short Title: ARST2032


Enrollment Status: Recruiting

NCT #: NCT05304585

Specialty Area: Pediatric Hematology/Oncology

Condition Studied: Rhabdomyosarcoma

Age Groups: Child; Adult

Phase: III


Study Information

Summary / Purpose

To evaluate the failure free survival of patients with very low-risk rhabdomyosarcoma when treated with 24 weeks of vincristine and dactinomycin; To evaluate the failure free survival of patients with low-risk rhabdomyosarcoma when treated with 12 weeks of vincristine, dactinomycin and cyclophosphamide followed by 12 weeks of vincristine and dactinomycin

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Children and Adults 21 years of age or younger
  • Must be enrolled on APEC14B and consented to the Molecular Characterization Initiative (Part A)
  • Newly diagnosed embryonal rhabdomyosarcoma, spindle cell/sclerosing rhabdomyosarcoma, or FOXO1 fusion negative alveolar rhabdomyosarcoma (institutional FOXO1 fusion results are acceptable)
  • For staging, patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease and patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease

What's Involved

Participation in the study will include:
  • Chemotherapy treatment based on risk level

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

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.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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