NCT07466316ClinicalTrials.gov

A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)

A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 3דרושים 342 משתתפים87 אתרים2 מדינות

קטגוריות

אונקולוגיה86%מחלות זיהומיות14%

רשום במרשם אחד

ClinicalTrials.govNCT07466316פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני 4 שבועות

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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 2026-03-12; recorded start 2026-07-14
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
Present: Participants are randomly assignedAllocation is recorded as 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 1 condition.
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 rigourMODERATE

A moderately rigorous design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
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: 65 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: 342 participants (target), run at 87 sites, across 2 countries.

How this score is built

Enrolment25/40
342 participants (target)
Site count21/25
65 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 57 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.

תקציר

This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.

PRIMARY OBJECTIVE: I. To determine if the event free survival (EFS) of patients with intermediate risk rhabdomyosarcoma (IR RMS) treated with surgery, radiotherapy, and vincristine, dactinomycin, cyclophosphamide (VAC) (2.2 g/m\^2/cycle cyclophosphamide) chemotherapy (regimen A) is better than that of patients treated with surgery, radiotherapy, and VAC alternating with vincristine, irinotecan (VI) (VAC/VI) (1.2 g/m\^2/cycle cyclophosphamide) chemotherapy plus 24 weeks of maintenance chemotherapy with vinorelbine and cyclophosphamide (regimen B). SECONDARY OBJECTIVES: I. To determine if the overall survival (OS) of patients with IR RMS treated with surgery and/or radiotherapy, and VAC (2.2 g/m\^2/cycle cyclophosphamide) chemotherapy (regimen A) is better than the OS of patients treated with surgery, radiotherapy, and VAC alternating with VI (VAC/VI) (1.2 g/m\^2/cycle cyclophosphamide) plus 24 weeks of maintenance chemotherapy with vinorelbine and cyclophosphamide (regimen B). II. To compare clinician-reported treatment-related adverse event (AE) rates between two regimens. III. To determine what proportion of patients deemed eligible for delayed primary excision (DPE) on retrospective central review undergo DPE and to assess the concordance of DPE eligibility between the central review and local site. IV. To compare the 4-year local failure (LF) rate of patients deemed DPE-eligible by retrospective central review who undergo DPE with the 4-year LF rate of patients deemed DPE-eligible by central review who do not undergo DPE. V. To determine the feasibility of reporting diagnostic tumor molecular features identified via the Molecular Characterization Initiative (MCI) within 6 weeks of treatment initiation for clinical group III patients. EXPLORATORY OBJECTIVES: I. To prospectively evaluate the following somatic molecular features (PAX3 or PAX7 and FOXO1 fusion, MYCN amplification, TP53 mutation, MYOD1 mutation, CDK4 amplification) via MCI and determine their association with EFS and OS. II. To explore the relationship between methylation patterns in IR RMS and EFS and OS. III. To test the use of digital pathology/artificial intelligence to refine the diagnosis of IR RMS. IV. To assess the differential impact of regimen intensity on gonadal toxicity experienced by patients. V. To determine the proportion of patients having fertility discussions and fertility preservation procedures prior to starting treatment. VI. To collect biospecimens for patient-derived xenograft (PDX) RMS model generation. VII. To bank biospecimens for future research. VIII. To evaluate the association between Household Material Hardship (HMH) measures and EFS and OS. OUTLINE: Patients are randomized to 1 of 2 regimens. REGIMEN A: CYCLES 1-4, 8, 12: Patients receive vincristine intravenously (IV) on days 1, 8 and 15 of each cycle, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, and cyclophosphamide IV over 1-6 hours on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. CYCLES 5, 9, 10, 13, 14: Patients receive vincristine IV on day 1 of each cycle, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, and cyclophosphamide IV over 1-6 hours on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. CYCLE 6: Patients receive vincristine IV on day 1 and cyclophosphamide IV over 1-6 hours on day 1. Cycle 6 continues for 21 days in the absence of disease progression or unacceptable toxicity. CYCLE 7: Patients receive vincristine IV on days 1, 8 and 15 and cyclophosphamide IV over 1-6 hours on day 1. Cycle 7 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo surgical resection during cycle 4 (week 12), radiation to the primary site during cycle 5 and 6 and/or radiation to distant metastatic sites during cycle 14. Patients do not receive dactinomycin during radiation. Patients undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Patients may undergo lymph node biopsy during screening and/or fludeoxyglucose (FDG) positron emission tomography (PET) scan, bone scan, bone marrow biopsy and aspiration, lumbar puncture with cerebrospinal fluid sample collection throughout the study. REGIMEN B: CYCLES 1, 3, 8: Patients receive vincristine IV on days 1, 8 and 15 of each cycle, dactinomycin IV over 15 or 10-15 minutes on day 1 of each cycle, and cyclophosphamide IV over 1-6 hours on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. CYCLES 2, 4, 11: Patients receive vincristine IV on days 1, 8 and 15 of each cycle and irinotecan IV over 90 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. CYCLES 5, 10, 12, 14: Patients receive vincristine IV on day 1 of each cycle, dactinomycin IV over 15 or 10-15 minutes on day 1 of each cycle, and cyclophosphamide IV over 1-6 hours on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. CYCLES 6, 7, 9, 13: Patients receive vincristine IV on days 1 and 8 of each cycle and irinotecan IV over 90 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo surgical resection during cycle 4 (week 12), radiation to the primary site during cycle 5 and 6 and/or radiation to distant metastatic sites during cycle 14. Patients do not receive dactinomycin during radiation. MAINTENANCE: Patients receive vinorelbine IV over 6-10 minutes on days 1, 8 and 15 of each cycle and cyclophosphamide orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or MRI and blood sample collection throughout the study. Patients may undergo lymph node biopsy during screening and/or FDG PET scan, bone scan, bone marrow biopsy and aspiration, lumbar puncture with cerebrospinal fluid sample collection throughout the study. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for years 2 and 3 then every 6 months for year 4 and 5.

מצבים רפואיים

Rhabdomyosarcoma

זכאות

זכאות
מין	הכול
גילאים	ללא מינימום – 50 Years
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: * Patient must be ≤ 50 years of age at the time of enrollment * Patients with newly diagnosed soft tissue RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon FOXO1 fusion status, Stage, Intergroup Rhabdomyosarcoma Study (IRS) group, and age, as below. FOXO1 fusion status must be determined prior to enrollment. RMS types included under embryonal rhabdomyosarcoma (ERMS) include those which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (typical, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar Rhabdomyosarcoma (ARMS) in the 2020 WHO Classification is the same as in the International Classification of Rhabdomyosarcoma (ICR) and includes classic and solid variants. * FOXO1 fusion negative (FN) * Stage 2/3, Group III * Stage 4, Group IV, \< 10 years old * FOXO1 fusion positive (FP) * Stages 1-3, Groups I-III * Disease/staging imaging studies, if applicable, must be obtained within 21 days prior to enrollment and start of protocol therapy (repeat if necessary) * FOXO1 status results must be available to enroll. All patients will undergo institutional pathology review and institutional FOXO1 fusion determination regardless of histology prior to enrollment. FOXO1 status may confirmed by cytogenetic, fluorescence in situ hybridization (FISH), or next generation sequencing techniques. FOXO1 fusion results should be SUBMITTED as an upload to RAVE at study enrollment because this information is required for randomization. Please note the following: * Institutional PAX3 versus (vs.) PAX7 determination is not required but should be submitted if available. Institutional FOXO1 testing may be performed at a contract or commercial lab as long as reports can be submitted and uploaded to RAVE. Additional molecular pathology reports, including the MCI report, are not required but should be submitted if available. * Patients who are \< 10 years old with distant metastatic disease (Stage 4) who have institutional molecular testing indicating fusion negative (FN) RMS but are later found to have fusion positive (FP) RMS by MCI or other testing will be considered to have metastatic FP disease and will go off study * Appropriate lymph node sampling based on primary site of disease is required * Patients must have a performance status of Lansky performance status score ≥ 50 for patients ≤ 16 years of age or Karnofsky performance status score ≥ 50 for patients \> 16 years of age * Peripheral absolute neutrophil count (ANC) ≥ 750/μL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.) * Platelet count ≥ 75,000/μL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.) * For pediatric patients \< 18 years of age: * A serum creatinine based on age/sex as follows: * 1 month to \< 6 months: Maximum serum creatinine 0.4 mg/dL (male), 0.4 mg/dL (female) * 6 months to \< 1 year: Maximum serum creatinine 0.5 mg/dL (male), 0.5 mg/dL (female) * 1 to \< 2 years: Maximum serum creatinine 0.6 mg/dL (male), 0.6 mg/dL (female) * 2 to \< 6 years: Maximum serum creatinine 0.8 mg/dL (male), 0.8 mg/dL (female) * 6 to \< 10 years: Maximum serum creatinine 1 mg/dL (male), 1 mg/dL (female) * 10 to \< 13 years: Maximum serum creatinine 1.2 mg/dL (male), 1.2 mg/dL (female) * 13 to \< 16 years: Maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female) * ≥ 16 years: Maximum serum creatinine 1.7 mg/dL (male),1.4 mg/dL (female) * OR a 24-hour urine Creatinine clearance ≥ 50 mL/min/1.73 m\^2 * OR a glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard). * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility. * Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible. However, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (ie, percutaneous nephrostomies or ureteric stents) of the urinary tract. For adult patients (aged 18 years or older): * Creatinine clearance ≥ 50 mL/min, as estimated by the Cockcroft and Gault formula or as a 24-hour urine collection. Estimated creatinine clearance is based on actual body weight. (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.) * If there is evidence of biliary obstruction by tumor, then total bilirubin must be \< 3 x ULN for age * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) ≤ 135 U/L (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L. * Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial Exclusion Criteria: * Patients with evidence of uncontrolled infection are not eligible * Previous or concurrent cancer(s) that is/was being treated with chemotherapy and/or radiation. * Note: Surgical resection alone of previous or concurrent cancer(s) is allowed * Patients with central nervous system involvement of RMS as defined below: * Malignant cells detected in cerebrospinal fluid * Intra-parenchymal brain metastases separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed) * Diffuse leptomeningeal disease * Patients with known Charcot-Marie-Tooth disease * Patients who have received any chemotherapy (excluding steroids) and/or radiation therapy for RMS prior to enrollment. Note: the following exception: * Patients requiring emergency radiation therapy for life-threatening complications of tumor burden due to RMS. These patients are eligible, provided they are consented to ARST2531 prior to administration of radiation. * Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (eg, autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy * 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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 342 משתתפים

נותן חסות ושותפים

Children's Oncology Group נותן חסות

זרועות והתערבויות

Regimen A (Higher cyclophosphamide dose regimenEXPERIMENTAL
See Detailed Description for Regimen A.
Regimen B (Lower cyclophosphamide dose, maintenance)EXPERIMENTAL
See Detailed Description for Regimen B.

התערבויות

פרוצדורה Biospecimen Collection
Undergo blood and cerebrospinal fluid sample collection
פרוצדורה Bone Marrow Aspiration
Undergo bone marrow aspiration
פרוצדורה Bone Marrow Biopsy
Undergo bone marrow biopsy
פרוצדורה Bone Scan
Undergo bone scan
פרוצדורה Computed Tomography
Undergo CT scan
תרופה Cyclophosphamide
Given IV and PO
ביולוגי Dactinomycin
Given IV
תרופה Irinotecan Hydrochloride
Given IV
פרוצדורה Lumbar Puncture
Undergo lumbar puncture
פרוצדורה Lymph Node Biopsy
Undergo lymph node biopsy
פרוצדורה Magnetic Resonance Imaging
Undergo MRI
פרוצדורה Positron Emission Tomography
Undergo FDG PET scan
קרינה Radiation Therapy
Undergo radiation therapy
פרוצדורה Resection
Undergo resection surgery
אחר Survey Administration
Ancillary studies
תרופה Vincristine Sulfate
Given IV
תרופה Vinorelbine Tartrate
Given IV

מדדי תוצאה

מדד תוצאה ראשוני
Event free survival (EFS)
Will be estimated using the Kaplan-Meier method and will be compared between the randomized treatment groups using the stratified log-rank test.
מסגרת זמן From randomization until the first occurrence of progression or relapse, second malignancy, or death, assessed up to 5 years
מדד תוצאה משני
Overall survival (OS)
Will be estimated using the Kaplan-Meier method and will be compared between the randomized treatment groups using the stratified log-rank test.
מסגרת זמן From randomization to death from any cause, assessed up to 4 years
מדד תוצאה משני
Clinician-reported adverse events (AEs)
Clinician-reported treatment-related grade 3 or higher AEs will be reported using Common Terminology Criteria for Adverse Events version 5.0. Comparison of toxicities will be conducted using Fisher's exact test. The maximum grade for each toxicity will be recorded for each patient. Averages and confidence intervals for these toxicity frequencies will be provided.
מסגרת זמן Up to 5 years
מדד תוצאה משני
Proportion of patients undergoing delayed primary excision (DPE) among patients deemed to be DPE eligible on retrospective central review
Eligibility for DPE will be established through a retrospective central review of diagnostic and pre-local control imaging. Among the patients deemed eligible for DPE, the proportion of those who undergo DPE will be determined along with 95% confidence interval. Cohen's kappa will be used to assess the concordance between site reviews and central reviews. 95% confidence of kappa statistics will be provided.
מסגרת זמן Up to week 12 of treatment
מדד תוצאה משני
Local failure rate for patients deemed eligible for DPE
Cumulative incidence curves will be used to present the local failure rates over time.
מסגרת זמן Up to 5 years
מדד תוצאה משני
Percentage of molecular biomarker testing that is resulted within the 6-week timeframe
Assessing the feasibility of reporting diagnostic tumor molecular features in patients with clinical group III intermediate risk rhabdomyosarcoma via the molecular characterization initiative (MCI) among the first 50 Clinical Group III patients who initiated treatment and consent to MCI. If 14 or more patients cannot have diagnostic tumor molecular features identified via MCI within 6 weeks of treatment, this aim will be considered not feasible.
מסגרת זמן Up to cycle 3 (each cycle is 21 days)
מדד תוצאה אחר
Somatic molecular features TP53 mutation
Binary (1 = Mutation present, 0 = Mutation absent) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Somatic molecular features MYCN amplification
Binary (1 = Amplified, 0 = Not amplified) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Somatic molecular features MYOD1 mutation
Binary (1 = Mutation present, 0 = Mutation absent) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Somatic molecular features CDK4 amplification
Binary (1 = Not amplified, 0 = Amplified) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Methylation patterns: EFS
Deoxyribonucleic acid (DNA) methylation data from rhabdomyosarcoma tumors collected during the conduct of ARST2531 will be analyzed. This data will be collected by array-based methods as part of MCI. The clinical significance of the rhabdomyosarcoma subsets determined in our DNA methylation studies will be analyzed. The association of DNA methylation subsets to EFS will be analyzed using the log-rank test and Cox model.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Methylation patterns: OS
DNA methylation data from rhabdomyosarcoma tumors collected during the conduct of ARST2531 will be analyzed. This data will be collected by array-based methods as part of MCI. The clinical significance of the rhabdomyosarcoma subsets determined in our DNA methylation studies will be analyzed. The association of DNA methylation subsets to OS will be analyzed using the log-rank test and Cox model.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Use of digital pathology/artificial intelligence: Risk predictions compared to EFS
Risk predictions will be recorded and ultimately compared to clinical outcomes, specifically 4-year EFS.
מסגרת זמן 4 years from study enrollment
מדד תוצאה אחר
Use of digital pathology/artificial intelligence: Risk predictions compared to OS
Risk predictions will be recorded and ultimately compared to clinical outcomes, specifically 4-year OS.
מסגרת זמן 4 years from study enrollment
מדד תוצאה אחר
Clinical practices of fertility discussions/procedures
Fertility consultation information (risk assessment, available fertility preservation options) will be collected and summarized using frequency and percentage. Frequency and percentage of eligible patients undergoing fertility preservation procedures will be summarized.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Patient derived xenograft rhabdomyosarcoma model generation
Will viably collect tumor samples for generation of patient-derived xenograft models that can be used in future research studies to advance the understanding of rhabdomyosarcoma biology.
מסגרת זמן Pre-treatment and cycle 3 (each cycle is 21 days)
מדד תוצאה אחר
Household material hardship (HMH)
HMH will be analyzed first as a binary variable (present/absent) and then as an ordinal (0-4) variable. Cox proportional hazard model will be used to assess the association between the binary HMH variable with EFS and OS. Then association between the ordinal measure and EFS and OS will be assessed using COX model.
מסגרת זמן At time of survey completion, from enrollment until start of cycle 3 (each cycle is 21 days)
מדד תוצאה אחר
EFS by treatment arm within racial subgroups
Will be estimated using the Kaplan-Meier method. The corresponding 95% confidence interval (CI) will be estimated using Peto-peto method.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
EFS by treatment arm within ethnicity subgroups
Will be estimated using the Kaplan-Meier method. The corresponding 95% CI will be estimated using Peto-peto method.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
EFS by treatment arm within sex subgroups
Will be estimated using the Kaplan-Meier method. The corresponding 95% CI will be estimated using Peto-peto method.
מסגרת זמן Up to 5 years

תאריכים

תאריכים
תאריך התחלה	14 ביולי 2026 (בפועל)
סיום ראשוני	31 במרץ 2031 (משוער)
סיום	31 במרץ 2031 (משוער)
פורסם לראשונה	12 במרץ 2026 (בפועל)
עודכן לאחרונה	25 באוגוסט 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	אוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

85 אתרים מגייסים

Canada

Canada
מתקן	עיר	מדינה או אזור	מצב
Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec	מגייס

United States

United States
מתקן	עיר	מדינה או אזור	מצב
Children's Hospital Medical Center of Akron	Akron	Ohio	מגייס
Albany Medical Center	Albany	New York	מגייס
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	מגייס
Mission Hospital	Asheville	North Carolina	מגייס
Children's Healthcare of Atlanta - Arthur M Blank Hospital	Atlanta	Georgia	מגייס
Children's Hospital Colorado	Aurora	Colorado	מגייס
Dell Children's Medical Center of Central Texas	Austin	Texas	מגייס
Sinai Hospital of Baltimore	Baltimore	Maryland	מגייס
MaineHealth Coastal Cancer Treatment Center	Bath	Maine	מגייס
Bronson Battle Creek	Battle Creek	Michigan	מגייס
Children's Hospital of Alabama	Birmingham	Alabama	מגייס
Dana-Farber Cancer Institute	Boston	Massachusetts	מגייס
University of Virginia Cancer Center	Charlottesville	Virginia	מגייס
University of Illinois	Chicago	Illinois	מגייס
Lurie Children's Hospital-Chicago	Chicago	Illinois	מגייס
Driscoll Children's Hospital	Corpus Christi	Texas	מגייס
UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	מגייס
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center	Denver	Colorado	מגייס
Blank Children's Hospital	Des Moines	Iowa	מגייס
City of Hope Comprehensive Cancer Center	Duarte	California	מגייס
Inova Fairfax Hospital	Falls Church	Virginia	מגייס
Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida	מגייס
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital	Grand Rapids	Michigan	מגייס
Trinity Health Grand Rapids Hospital	Grand Rapids	Michigan	מגייס
Corewell Health Grand Rapids Hospitals - Butterworth Hospital	Grand Rapids	Michigan	מגייס
Connecticut Children's Medical Center	Hartford	Connecticut	מגייס
Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida	מגייס
Riley Hospital for Children	Indianapolis	Indiana	מגייס
University of Mississippi Medical Center	Jackson	Mississippi	מגייס
Nemours Children's Clinic-Jacksonville	Jacksonville	Florida	מגייס
Bronson Methodist Hospital	Kalamazoo	Michigan	מגייס
West Michigan Cancer Center	Kalamazoo	Michigan	מגייס
Beacon Kalamazoo	Kalamazoo	Michigan	מגייס
Children's Mercy Hospitals and Clinics	Kansas City	Missouri	מגייס
East Tennessee Childrens Hospital	Knoxville	Tennessee	מגייס
University of Kentucky/Markey Cancer Center	Lexington	Kentucky	טרם מגייס
Arkansas Children's Hospital	Little Rock	Arkansas	מגייס
Loma Linda University Medical Center	Loma Linda	California	מגייס
Cedars-Sinai Medical Center	Los Angeles	California	מגייס
Mattel Children's Hospital UCLA	Los Angeles	California	מגייס
Norton Children's Hospital	Louisville	Kentucky	מגייס
Valley Children's Hospital	Madera	California	מגייס
University of Wisconsin Carbone Cancer Center - University Hospital	Madison	Wisconsin	מגייס
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center	Madison	Wisconsin	מגייס
Children's Hospital of Wisconsin	Milwaukee	Wisconsin	מגייס
USA Health Strada Patient Care Center	Mobile	Alabama	מגייס
Trinity Health Muskegon Hospital	Muskegon	Michigan	מגייס
The Children's Hospital at TriStar Centennial	Nashville	Tennessee	מגייס
Corewell Health Lakeland Hospitals - Niles Hospital	Niles	Michigan	מגייס

37 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

25 באוגוסט 2026
אתר נוסף
2 sites added (87 total)
8587
21 באוגוסט 2026
אתר נוסף
20 sites added (85 total)
6585
30 ביולי 2026
המצב השתנה
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
30 ביולי 2026
הגיוס נפתח
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
30 ביולי 2026
אתר נוסף
65 sites added (65 total)
065

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07466316