OncoMatch/Clinical Trials/NCT05304585
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
Is NCT05304585 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Dactinomycin and Cyclophosphamide for embryonal rhabdomyosarcoma.
Treatment: Cyclophosphamide · Dactinomycin · Vincristine — 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 rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
Check if I qualifyExtracted eligibility criteria
Cancer type
Rhabdomyosarcoma
Biomarker criteria
Required: FOXO1 fusion negative
Disease stage
Required: Stage STAGE 1, STAGE 2
Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease. 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.
Prior therapy
Cannot have received: chemotherapy
Exception: surgical resection alone of previous cancer(s) is permitted; chemotherapy for non-malignant conditions is permitted if discontinued prior to protocol therapy
Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted. Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
Cannot have received: radiation therapy
Exception: surgical resection alone of previous cancer(s) is permitted; radiation for non-malignant conditions is permitted if discontinued prior to protocol therapy
Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted. Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
Lab requirements
Blood counts
ANC >= 750/uL; Platelet count >= 75,000/uL (transfusion independent)
Kidney function
Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 or serum creatinine below age/gender-specific thresholds
Liver function
Total bilirubin <= 1.5 x ULN for age (or < 3 x ULN if biliary obstruction); SGPT (ALT) <= 135 U/L (ULN for SGPT/ALT set to 45 U/L)
Peripheral absolute neutrophil count (ANC) >= 750/uL (within 7 days prior to enrollment). Platelet count >= 75,000/uL (transfusion independent) (within 7 days prior to enrollment). Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine (within 7 days prior to enrollment) based on age/gender as follows: ... Total bilirubin <= 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and if there is evidence of biliary obstruction by the tumor, then the total bilirubin must be < 3 x ULN for age. Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L. Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) <= 135 U/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- USA Health Strada Patient Care Center · Mobile, Alabama
- Phoenix Childrens Hospital · Phoenix, Arizona
- Arkansas Children's Hospital · Little Rock, Arkansas
- Kaiser Permanente Downey Medical Center · Downey, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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