NCT05304585ClinicalTrials.gov

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

A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

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En resumen

Fase 3205 participantes buscados181 centros4 países

Categorías

Oncología100%

Registrado en 1 registro

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-03-31; recorded start 2022-08-04
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 183 other studies in this databaseCounted from the lead sponsor named in the record (Children's Oncology Group)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: research network.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Non-randomised allocation
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 180 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 205 participants (target), run at 181 sites, across 4 countries.

How this score is built

Enrolment22/40
205 participants (target)
Site count25/25
180 sites
Country count7/15
4 countries
Planned duration10/10
Planned over about 96 months
Sponsor scale9/10
Children's Oncology Group has led 182 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

PRIMARY OBJECTIVES: I. To evaluate the failure free survival (FFS) of patients with very low-risk (VLR) rhabdomyosarcoma (RMS) (fusion negative \[FN\], stage 1, clinical group \[CG\] I, MYOD1 wildtype \[WT\], TP53 \[WT\]) when treated with 24 weeks of vincristine and dactinomycin (VA). II. To evaluate the FFS of patients with low-risk (LR) RMS (FN, stage 1 CG II, or stage 2 CG I/II or CG III \[orbit only\], MYOD1 WT, TP53 WT) when treated with 12 weeks of vincristine, dactinomycin and cyclophosphamide (VAC) followed by 12 weeks of VA. SECONDARY OBJECTIVES: I. To evaluate the overall survival (OS) of patients with VLR RMS treated with 24 weeks of VA. II. To evaluate the OS of patients with LR RMS treated with 12 weeks of VAC followed by 12 weeks of VA. III. To demonstrate the feasibility of central molecular risk stratification of patients with newly diagnosed RMS in the context of a prospective clinical trial. EXPLORATORY OBJECTIVES: I. To collect blood and tissue samples for banking at baseline, during treatment, at the end of therapy, and at the time of progression to bank for future research. II. To describe the methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma. III. To describe the outcomes of patients with VLR or LR RMS and MYOD1 or TP53 mutations treated with intensified therapy. OUTLINE: Patients are assigned to 1 of 2 regimens based on clinical features. Patients with positive mutation status are transitioned to a third regimen, Regimen M. REGIMEN VA: Patients with VLR RMS receive vincristine intravenously (IV) on day 1 of each cycle and days 8 and 15 of cycles 1, 3, 5, and 7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). REGIMEN VAC/VA: Patients with LR RMS receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 1-3. Patients also receive dactinomycin IV over 1-5 minutes or 10-15 minutes and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 5-7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Patients may also undergo radiation therapy at cycle 5. REGIMEN M: Patients receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 2-4, 7-8, and 11-12 and dactinomycin IV over 1-5 minutes or 10-15 minutes on day 1 of cycles 2-5 and 8-14. Patients also receive cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 12-13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo radiation therapy at cycle 5. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, positron emission tomography (PET) scan and tumor biopsy throughout the study.

Afecciones

Embryonal Rhabdomyosarcoma
Fusion-Negative Alveolar Rhabdomyosarcoma
Spindle Cell/Sclerosing Rhabdomyosarcoma

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	Sin mínimo – 21 Years
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Inclusion Criteria: * All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial). * Patients must be =\< 21 years at the time of enrollment. * Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients. * All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed. * 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. * Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging. * Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors. * Clinically or radiographically enlarged nodes must be sampled for histologic evaluation. * Patients must have a Lansky (for patients =\< 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of \>= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score. * 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: * Age: 1 month to \< 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4 (female) * Age: 6 months to \< 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5 (female) * Age: 1 to \< 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female) * Age: 2 to \< 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female) * Age: 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female) * Age: 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2 (female) * Age: 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4 (female) * Age \>= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female) * 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 * 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 * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Exclusion Criteria: * 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. * Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment. * Patients unable to undergo radiation therapy, if necessary, as specified in the protocol. * Evidence of uncontrolled infection. * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. * Lactating females who plan to breastfeed their infants. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 3
Asignación	No aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	205 participantes buscados

Patrocinador y colaboradores

Children's Oncology Group Patrocinador
National Cancer Institute (NCI) Colaboradores

Grupos e intervenciones

Regimen M (positive mutation)EXPERIMENTAL
Patients receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 2-4, 7-8, and 11-12 and dactinomycin IV over 1-5 minutes or 10-15 minutes on day 1 of cycles 2-5 and 8-14. Patients also receive cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 12-13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo radiation therapy at cycle 5. Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Regimen VA (VLR RMS)EXPERIMENTAL
Patients with VLR RMS receive vincristine intravenously (IV) on day 1 of each cycle and days 8 and 15 of cycles 1, 3, 5, and 7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Regimen VAC/VA (VL RMS)EXPERIMENTAL
Patients with LR RMS receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 1-3. Patients also receive dactinomycin IV over 1-5 minutes or 10-15 minutes and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 5-7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Radiation therapy (if needed) will be administered at cycle 5.Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.

Intervenciones

Procedimiento Biopsy Procedure
Undergo tumor biopsy
Procedimiento Bone Scan
Undergo bone scan
Procedimiento Computed Tomography
Undergo CT scan
Fármaco Cyclophosphamide
Given IV
Biológico Dactinomycin
Given IV
Procedimiento Magnetic Resonance Elastography
Undergo MRI
Procedimiento Positron Emission Tomography
Undergo PET scan
Radiación Radiation Therapy
Undergo radiation
Fármaco Vincristine
Given IV

Variables de resultado

Variable de resultado principal
Failure free survival (FFS) for very low risk patients
The Kaplan-Meier method will be used to estimate 3-year FFS along with 80% log-minus-log transformed confidence limits for very low risk (VLR) patients.
Plazo From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years
Variable de resultado principal
Failure free survival (FFS) for low risk patients
The Kaplan-Meier method will be used to estimate 3 year FFS along with 80% log-minus-log transformed confidence limits for low risk (LR) patients.
Plazo From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years
Variable de resultado secundaria
Overall survival (OS) for very low risk patients
Log-rank test will be used to compare the OS of patients with VLR rhabdomyosarcoma (RMS) treated with 24 weeks of vincristine, dactinomycin (VA) to the VLR RMS patients from ARST0331 and D9602 with the same inclusion criteria.
Plazo From study entry to death of any cause, assessed up to 5 years
Variable de resultado secundaria
Overall survival (OS) for low risk patients
Log-rank test will be used to compare the OS from LR RMS patients to LR RMS patients from ARST0331 and D9602 with the same inclusion criteria.
Plazo From study entry to death of any cause, assessed up to 5 years
Variable de resultado secundaria
Feasibility of central molecular risk stratification of patients assessed by the percentage of patients who have molecular testing results returned by 6 weeks
If the percentage of patients who have molecular testing results returned by 6 weeks is \>= 80% then the central molecular risk stratification is considered feasible.
Plazo Up to 24 weeks
Otra variable de resultado
Methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma
Summary statistics will be used to describe the methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma. Correlation between methylation patterns and clinical presentation, histology, and genetics will be evaluated.
Plazo Up to 5 years
Otra variable de resultado
Descriptive analysis of patients treated on Regimen M
Summary statistics will be used to provide a descriptive analysis of patients treated on Regimen M, including patient demographics, clinical characteristics and outcomes.
Plazo Up to 5 years

Fechas

Fechas
Fecha de inicio	4 de agosto de 2022 (real)
Finalización principal	30 de junio de 2030 (estimada)
Finalización	30 de junio de 2030 (estimada)
Primera publicación	31 de marzo de 2022 (real)
Última actualización	25 de agosto de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	octubre de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

178 centros están en reclutamiento

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Perth Children's Hospital	Perth	Western Australia	En reclutamiento
Sydney Children's Hospital	Randwick	New South Wales	En reclutamiento
The Children's Hospital at Westmead	Westmead	New South Wales	En reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Alberta Children's Hospital	Calgary	Alberta	En reclutamiento
University of Alberta Hospital	Edmonton	Alberta	En reclutamiento
IWK Health Centre	Halifax	Nova Scotia	En reclutamiento
Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec	En reclutamiento
The Montreal Children's Hospital of the MUHC	Montreal	Quebec	En reclutamiento
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)	Québec		En reclutamiento
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec	Suspendido
Hospital for Sick Children	Toronto	Ontario	En reclutamiento
British Columbia Children's Hospital	Vancouver	British Columbia	En reclutamiento
CancerCare Manitoba	Winnipeg	Manitoba	En reclutamiento

New Zealand

New Zealand
Centro	Ciudad	Estado o región	Estado
Christchurch Hospital	Christchurch		En reclutamiento
Starship Children's Hospital	Grafton	Auckland	En reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Children's Hospital Medical Center of Akron	Akron	Ohio	En reclutamiento
Albany Medical Center	Albany	New York	En reclutamiento
University of New Mexico Cancer Center	Albuquerque	New Mexico	En reclutamiento
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	En reclutamiento
C S Mott Children's Hospital	Ann Arbor	Michigan	En reclutamiento
Children's Healthcare of Atlanta - Arthur M Blank Hospital	Atlanta	Georgia	En reclutamiento
Children's Hospital Colorado	Aurora	Colorado	En reclutamiento
Dell Children's Medical Center of Central Texas	Austin	Texas	En reclutamiento
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	En reclutamiento
Sinai Hospital of Baltimore	Baltimore	Maryland	En reclutamiento
University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	En reclutamiento
Children's Hospital of Alabama	Birmingham	Alabama	En reclutamiento
Saint Luke's Cancer Institute - Boise	Boise	Idaho	En reclutamiento
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	En reclutamiento
Dana-Farber Cancer Institute	Boston	Massachusetts	En reclutamiento
Roswell Park Cancer Institute	Buffalo	New York	En reclutamiento
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	En reclutamiento
West Virginia University Charleston Division	Charleston	West Virginia	En reclutamiento
Medical University of South Carolina	Charleston	South Carolina	En reclutamiento
Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	En reclutamiento
Novant Health Presbyterian Medical Center	Charlotte	North Carolina	En reclutamiento
University of Virginia Cancer Center	Charlottesville	Virginia	En reclutamiento
University of Chicago Comprehensive Cancer Center	Chicago	Illinois	En reclutamiento
University of Illinois	Chicago	Illinois	Suspendido
Lurie Children's Hospital-Chicago	Chicago	Illinois	En reclutamiento
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	En reclutamiento
Cleveland Clinic Foundation	Cleveland	Ohio	En reclutamiento
Rainbow Babies and Childrens Hospital	Cleveland	Ohio	En reclutamiento
Prisma Health Richland Hospital	Columbia	South Carolina	En reclutamiento
Nationwide Children's Hospital	Columbus	Ohio	En reclutamiento
Driscoll Children's Hospital	Corpus Christi	Texas	En reclutamiento
Medical City Dallas Hospital	Dallas	Texas	En reclutamiento
UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	En reclutamiento
Geisinger Medical Center	Danville	Pennsylvania	En reclutamiento
Dayton Children's Hospital	Dayton	Ohio	En reclutamiento

En el registro figuran 131 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

25 de agosto de 2026
Centro añadido
1 site added (181 total)
180181

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05304585