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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 (Jun 2026). This Phase 1/2 trial studies multiple treatments for rhabdomyosarcoma.

Phase 1/2RecruitingUniversity of BirminghamNCT04625907Data as of Jun 2026Location: International · 20 countries

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

Treatments studied

Targeted therapy

Regorafenib

Chemotherapy

IrinotecanDoxorubicinIfosfamideVincristineVinorelbineCyclophosphamideTemozolomide

Other

Actinomycin D

Cancer type

Rhabdomyosarcoma

Demographics

Ages 0.5–25

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.

Frequently asked questions

Is NCT04625907 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior stem cell transplant, regorafenib, temozolomide disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 25 years or younger and at least 0.5 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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