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OncoMatch/Clinical Trials/NCT04625907

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

Is NCT04625907 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for rhabdomyosarcoma.

Phase 1/2RecruitingUniversity of BirminghamNCT04625907Data as of May 2026

Treatment: Irinotecan · Actinomycin D · Doxorubicin · Ifosfamide · Vincristine · Vinorelbine · Cyclophosphamide · Temozolomide · RegorafenibFaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)

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Extracted eligibility criteria

Cancer type

Rhabdomyosarcoma

Prior therapy

Cannot have received: stem cell transplant

Prior allo- or autologous Stem Cell Transplant

Cannot have received: regorafenib (regorafenib)

Prior regorafenib

Cannot have received: temozolomide (temozolomide)

Prior temozolomide

Lab requirements

Blood counts

Absolute neutrophil count ≥1.0x 10^9/L; Platelets ≥ 80 x 10^9/L

Kidney function

estimated or measured creatinine clearance ≥60 ml/min/1.73 m2

Liver function

Total bilirubin ≤ 1.5 x ULN for age (unless Gilbert's syndrome); ALT or AST < 2.5 x ULN for age (IRIVA); ALT or AST >3.0 x ULN [excluded, CT3]; Bilirubin, Total >1.5 x ULN [excluded, CT3]; total bilirubin is allowed up to 3 x ULN if Gilbert's syndrome is documented

Cardiac function

Fractional Shortening ≥ 28% (CT1a); Absence of severe vincristine neuropathy; No unstable angina, recent MI, cardiac failure NYHA ≥2, congestive heart failure (Modified Ross ≥2), or cardiac arrhythmias requiring antiarrhythmic therapy (CT3)

Adequate hepatic function: Total bilirubin ≤ 1.5 x ULN for age (unless Gilbert's syndrome); ALT or AST < 2.5 x ULN for age; Absolute neutrophil count ≥1.0x 10^9/L; Platelets ≥ 80 x 10^9/L; Adequate renal function: estimated or measured creatinine clearance ≥60 ml/min/1.73 m2; Fractional Shortening ≥ 28%; Absence of severe vincristine neuropathy; No unstable angina, recent MI, cardiac failure NYHA ≥2, congestive heart failure (Modified Ross ≥2), or cardiac arrhythmias requiring antiarrhythmic therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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