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New trial seeks best chemo strategy for childhood muscle cancer

NCT ID NCT07466316

Disease control Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 5 times

Summary

This study compares two chemotherapy plans for people with newly diagnosed intermediate-risk rhabdomyosarcoma, a type of muscle cancer. One group gets a higher dose of chemo over a shorter time, while the other gets a lower dose over a longer time plus extra maintenance drugs. The goal is to see which approach works better and has fewer side effects. About 342 participants up to age 50 will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 342 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rhabdomyosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rhabdomyosarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    87 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Alfred I duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202-3591, United States

  • Beacon Kalamazoo

    RECRUITING

    Kalamazoo, Michigan, 49048, United States

  • Blank Children's Hospital

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Bronson Battle Creek

    RECRUITING

    Battle Creek, Michigan, 49017, United States

  • Bronson Methodist Hospital

    RECRUITING

    Kalamazoo, Michigan, 49007, United States

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    SUSPENDED

    Norton Shores, Michigan, 49444, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Centre Hospitalier Universitaire Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital and Medical Center of Omaha

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of The King's Daughters

    RECRUITING

    Norfolk, Virginia, 23507, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

    Contact Email: •••••@•••••

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    RECRUITING

    Saint Joseph, Michigan, 49085, United States

  • Corewell Health Lakeland Hospitals - Niles Hospital

    RECRUITING

    Niles, Michigan, 49120, United States

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    RECRUITING

    Saint Joseph, Michigan, 49085, United States

  • Corewell Health Reed City Hospital

    RECRUITING

    Reed City, Michigan, 49677, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dell Children's Medical Center of Central Texas

    RECRUITING

    Austin, Texas, 78723, United States

  • Driscoll Children's Hospital

    RECRUITING

    Corpus Christi, Texas, 78411, United States

  • East Tennessee Childrens Hospital

    RECRUITING

    Knoxville, Tennessee, 37916, United States

  • Golisano Children's Hospital of Southwest Florida

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • Inova Fairfax Hospital

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Legacy Emanuel Children's Hospital

    RECRUITING

    Portland, Oregon, 97227, United States

  • Lehigh Valley Hospital-Cedar Crest

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92354, United States

  • Lurie Children's Hospital-Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Maine Children's Cancer Program

    RECRUITING

    Scarborough, Maine, 04074, United States

    Contact Email: •••••@•••••

  • MaineHealth Cancer Care Center of York County

    RECRUITING

    Sanford, Maine, 04073, United States

  • MaineHealth Coastal Cancer Treatment Center

    RECRUITING

    Bath, Maine, 04530, United States

  • MaineHealth Maine Medical Center - Portland

    RECRUITING

    Portland, Maine, 04102, United States

    Contact Email: •••••@•••••

  • MaineHealth Maine Medical Center- Scarborough

    RECRUITING

    Scarborough, Maine, 04074, United States

    Contact Email: •••••@•••••

  • Mary Bridge Children's Hospital and Health Center

    RECRUITING

    Tacoma, Washington, 98405, United States

    Contact Email: •••••@•••••

  • Mattel Children's Hospital UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Mercy Hospital Saint Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Methodist Children's Hospital of South Texas

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Mission Hospital

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Munson Medical Center

    RECRUITING

    Traverse City, Michigan, 49684, United States

  • Nemours Children's Clinic - Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

    Contact Email: •••••@•••••

  • Nemours Children's Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Hospital

    RECRUITING

    Orlando, Florida, 32827, United States

  • Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

    Contact Email: •••••@•••••

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

    Contact Email: •••••@•••••

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

    RECRUITING

    Denver, Colorado, 80218, United States

    Contact Email: •••••@•••••

  • Saint Christopher's Hospital for Children

    RECRUITING

    Philadelphia, Pennsylvania, 19134, United States

  • Saint Mary's Medical Center

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Sinai Hospital of Baltimore

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • The Children's Hospital at TriStar Centennial

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Trinity Health Grand Rapids Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Trinity Health Muskegon Hospital

    RECRUITING

    Muskegon, Michigan, 49444, United States

  • UMass Memorial Medical Center - University Campus

    RECRUITING

    Worcester, Massachusetts, 01655, United States

    Contact Email: •••••@•••••

  • USA Health Strada Patient Care Center

    RECRUITING

    Mobile, Alabama, 36604, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Kentucky/Markey Cancer Center

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Michigan Health - West

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Valley Children's Hospital

    RECRUITING

    Madera, California, 93636, United States

    Contact Email: •••••@•••••

  • Wesley Medical Center

    RECRUITING

    Wichita, Kansas, 67214, United States

    Contact Email: •••••@•••••

  • West Michigan Cancer Center

    RECRUITING

    Kalamazoo, Michigan, 49007, United States

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