ClinicalTrials.gg
Active, not recruitingNCT04994132Updated Jul 30, 2026

A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma

A Phase 3 interventional study of Biospecimen Collection and Bone Marrow Aspiration in Alveolar Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma and Embryonal Rhabdomyosarcoma, sponsored by Children's Oncology Group. Active, not recruiting at 250 sites in 5 countries. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Children's Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
Up to 50 Years
Sex
All
01

Study summary

This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

Read the detailed description

PRIMARY OBJECTIVE:

I. To compare event-free survival (EFS) of patients with high-risk rhabdomyosarcoma (HR-RMS) treated with vinorelbine, dactinomycin and cyclophosphamide (VINO-AC) followed by 24 weeks of vinorelbine and oral cyclophosphamide (VINO-CPO) maintenance therapy to that of patients treated with vincristine, dactinomycin and cyclophosphamide (VAC) followed by 24 weeks of VINO-CPO maintenance therapy.

SECONDARY OBJECTIVES:

I. To assess the safety and feasibility of administering VINO-AC in newly diagnosed patients with HR-RMS.

II. To describe the toxicity experience of patients with HR-RMS treated with VINO-AC compared to VAC.

III. To compare overall survival (OS) of patients with HR-RMS treated with VINO AC followed by 24 weeks of VINO-CPO maintenance therapy to that of patients treated with VAC followed by 24 weeks of VINO-CPO maintenance therapy.

IV. To compare objective radiologic response rates at week 12 between patients with HR-RMS treated with VINO-AC to those treated with VAC.

V. To determine whether the addition of 24 weeks of VINO-CPO maintenance therapy improves EFS in patients with HR-RMS when compared to historical controls.

VI. To determine the association between circulating tumor-derived deoxyribonucleic acid (ctDNA) levels at diagnosis and during initial chemotherapy and event-free survival (EFS) in patients with HR RMS.

VII. To prospectively validate the prognostic impact of genomic variants in HR RMS.

EXPLORATORY OBJECTIVE:

I. To collect serial blood samples and tumor tissue for banking at baseline, during treatment, at the end of therapy, and at the time of progression for future tumor and liquid biopsy studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive vincristine sulfate intravenously (IV) on days 1, 8 and 15 of cycles 1-4, 7, 8, 11, and 12, and day 1 of cycles 5, 6, 9, 10, 13, and 14. Patients also receive dactinomycin IV over 1-15 minutes or IV push (IVP) over 1-5 minutes on day 1 of cycles 1-5, 8-10, and 11-14, and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40.

ARM B: Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 and 8, vincristine sulfate IV on day 15, dactinomycin IV over 1-15 minutes or IVP over 1-5 minutes on day 1 of cycles 1-5 and 8-14, and cyclophosphamide IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40.

MAINTENANCE: All patients receive vinorelbine tartrate IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients in both arms undergo computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), x-ray imaging, and/or bone scan, as well as blood sample collection throughout the trial. Patients may also undergo bone marrow aspiration and/or biopsy as clinically indicated

After completion of study treatment, patients are followed up every 3 months for year 1, every 4 months for years 2-3, and every 6 months for years 4-5.

02

Conditions studied

  • Alveolar Rhabdomyosarcoma
  • Botryoid-Type Embryonal Rhabdomyosarcoma
  • Embryonal Rhabdomyosarcoma
  • Metastatic Embryonal Rhabdomyosarcoma
  • Metastatic Rhabdomyosarcoma
  • Solid Alveolar Rhabdomyosarcoma
  • Spindle Cell Rhabdomyosarcoma
  • Spindle Cell/Sclerosing Rhabdomyosarcoma
03

In context

Rhabdomyosarcoma, Embryonal

9 studies on the registry are indexed under Rhabdomyosarcoma, Embryonal; 3 are open to participants now.

Browse Rhabdomyosarcoma, Embryonal studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 448 studies on the registry; 36 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must be =\< 50 years of age at the time of enrollment
  • Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification are eligible to enroll on the study based upon stage, group, and age, as below. FOXO1 fusion status must be determined by week 4 (day 28) of therapy. RMS types included under embryonal RMS (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). Classification of alveolar RMS (ARMS) in the 2020 WHO Classification is the same as in the ICR and includes classic and solid variants

    • ERMS

      • Stage 4, group IV, >= 10 years of age
    • ARMS

      • Stage 4, group IV Patients will be eligible to remain on protocol therapy based upon stage, group, and age
  • Bone marrow disease is based on morphologic evidence of RMS based on hematoxylin and eosin (H\&E) stains. In the absence of morphologic evidence of marrow involvement on H\&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study
  • or radioisotope (GFR) >= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/sex as follows (must be performed within 7 days prior to enrollment):

    • Age; Maximum serum creatinine (mg/dL)
    • 1 month to \< 6 months; 0.4 mg/dL (male); 0.4 mg/dL (female)
    • 6 months to \< 1 year; 0.5 mg/dL (male); 0.5 mg/dL (female)
    • 1 to \< 2 years; 0.6 mg/dL (male); 0.6 mg/dL (female)
    • 2 to \< 6 years; 0.8 mg/dL (male); 0.8 mg/dL (female)
    • 6 to \< 10 years; 1 mg/dL (male); 1 mg/dL (female)
    • 10 to \< 13 years; 1.2 mg/dL (male); 1.2 mg/dL (female)
    • 13 to \< 16 years; 1.5 mg/dL (male); 1.4 mg/dL (female)
    • >= 16 years; 1.7 mg/dL (male); 1.4 mg/dL (female)
  • Total =\< 1.5 x (ULN) for age (must be performed within 7 days prior to enrollment)

    • If there is evidence of biliary obstruction by tumor, then total bilirubin must be \< 3 x ULN for age
  • All patients and/or their parents or legal guardians must sign a written
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion criteria

Exclusion Criteria:

  • Patients with evidence of uncontrolled infection are not eligible
  • RMS that is considered a second and previous cancer(s) that were treated with chemotherapy and/or radiation. Surgical resection alone of previous cancer(s) is allowed
  • Patients with central nervous system involvement of RMS as defined below:

    • Malignant cells detected in cerebrospinal fluid
    • Intra-parenchymal separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed).
    • Diffuse
  • Patients who have received any chemotherapy (excluding ) and/or radiation therapy for RMS prior to enrollment.

    • Note: the following exception:

      • Patients requiring emergency radiation therapy for RMS. These patients are eligible, provided they are consented to ARST2031 prior to administration of radiation
    • Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (e.g. diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy
  • Vincristine and vinorelbine are sensitive substrates of CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong inhibitors and inducers within 7 days prior to study enrollment
  • 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
  • Lactating females who plan to breastfeed their infants
  • Sexually active patients of who have not agreed to use an effective method for the duration of their study participation
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
113 participants (actual)

Study arms

  • Experimental
    Arm A (VAC, VINO-CPO)

    Patients receive vincristine sulfate IV on days 1, 8 and 15 of cycles 1-4, 7, 8, 11, and 12, and day 1 of cycles 5, 6, 9, 10, 13, and 14. Patients also receive dactinomycin IV over 1-15 minutes or IVP over 1-5 minutes on day 1 of cycles 1-5, 8-10, and 11-14, and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40. MAINTENANCE: Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1, 8, and 15, and cyclophosphamide PO on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms undergo CT, MRI, PET, x-ray imaging, and/or bone scan, as well as blood sample collection throughout the trial. Patients may also undergo bone marrow aspiration and/or biopsy as clinically indicated.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Procedure: Bone Marrow Biopsy · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Cyclophosphamide · Biological: Dactinomycin · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Radiation: Radiation Therapy · Drug: Vincristine Sulfate · Drug: Vinorelbine Tartrate · Procedure: X-Ray Imaging

  • Experimental
    Arm B (vinorelbine, VAC, VINO-CPO)

    Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 and 8, vincristine sulfate IV on day 15, dactinomycin IV over 1-15 minutes or IVP over 1-5 minutes on day 1 of cycles 1-5 and 8-14, and cyclophosphamide IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40. MAINTENANCE: Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1, 8, and 15, and cyclophosphamide PO on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms undergo CT, MRI, PET, x-ray imaging, and/or bone scan, as well as blood sample collection throughout the trial. Patients may also undergo bone marrow aspiration and/or biopsy as clinically indicated.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Procedure: Bone Marrow Biopsy · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Cyclophosphamide · Biological: Dactinomycin · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Radiation: Radiation Therapy · Drug: Vincristine Sulfate · Drug: Vinorelbine Tartrate · Procedure: X-Ray Imaging

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureBone Marrow Aspiration

    Undergo bone marrow aspiration

  • ProcedureBone Marrow Biopsy

    Undergo bone marrow biopsy

    Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

  • ProcedureBone Scan

    Undergo bone scan

    Also known as: Bone Scintigraphy

  • ProcedureComputed Tomography

    Undergo CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • Given IV or PO

    Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Frindovyx, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

  • BiologicalDactinomycin

    Given IV

    Also known as: Actinomycin A IV, Actinomycin C1, Actinomycin D, Actinomycin I1, Actinomycin IV, Actinomycin X 1, Actinomycin-[thr-val-pro-sar-meval], Cosmegen, DACT, Dactinomycine, Lyovac Cosmegen, Meractinomycin

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • ProcedurePositron Emission Tomography

    Undergo PET

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • RadiationRadiation Therapy

    Undergo radiation therapy

    Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

  • Given IV

    Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

  • Given IV

    Also known as: Biovelbin, Eunades, KW 2307, KW-2307, KW2307, Navelbine, Navelbine Ditartrate, NVB, Vinorelbine Ditartrate

  • ProcedureX-Ray Imaging

    Undergo x-ray imaging

    Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray

06

What researchers measure

Primary outcomes

  1. Event-free survival (EFS)

    Will be estimated using the Kaplan-Meier method and will be compared between the two regimens using a log-rank test.

    Time frame: Time from randomization to an event defined as disease relapse/progression, second malignancy, or death, whichever occurs first, assessed up to 5 years from study enrollment

Secondary outcomes

  1. Overall survival

    Will be estimated using the Kaplan-Meier method and will be compared between the therapy groups using a log-rank test.

    Time frame: Time from randomization to death of any cause, assessed up to 5 years from study enrollment

  2. Radiologic response rate

    Includes both complete response and partial response. Response Evaluation Criteria in Solid Tumors 1.1 criteria will be used to define complete and partial responses. Will be compared between arms using chi square test.

    Time frame: At week 12 after study enrollment

  3. Incidence of adverse events

    Adverse events of particular interest including grade 4 hematologic toxicity, grade 2 sinusoidal obstruction syndrome, grade 3 or higher neuropathy and any non-hematologic toxicity that result in delays \> 14 days in the delivery of a 21-day cycle of therapy or results in a dose reduction of any chemotherapy drugs.

    Time frame: Up to 5 years from study enrollment

  4. Feasibility and safety assessed by the adverse events, toxicities and treatment delays

    If more than 40% of patients enrolled in the safety phase experience one or more of the toxicities, the study will be paused, the study team will review the data and determine if an amendment is needed. Specifically, toxicities of interest include: 1. Hematological toxicities that delay the administration of subsequent chemotherapy cycles by more than two weeks. 2. Grade 2 or higher sinusoidal obstruction syndrome. 3. Grade 3 or higher neuropathy. 4. Other Grade 3 or higher non-hematological toxicities that delay the administration of subsequent chemotherapy cycles by more than 2 weeks.

    Time frame: From study enrollment to completion of the initial 12 weeks of therapy

  5. Association between circulating tumor-derived deoxyribonucleic acid (ctDNA) and EFS

    Will use Kaplan-Meier methods to calculate EFS, defined as the time from randomization to an event defined as disease relapse/progression, second malignancy, or death, whichever occurs first, for patients with and without detectable ctDNA. Will classify patients as having detectable or undetectable ctDNA at baseline. Will compare EFS between these two groups using a one-sided log-rank test.

    Time frame: Up to 5 years from study enrollment

  6. Prognostic impact of genomic variants

    Will provide descriptive statistics for amplifications in MYCN and mutations in TP53 and MYOD1. Will compare EFS between patients with and without these mutations detected at baseline.

    Time frame: Up to 5 years from study enrollment

07

Study locations

250 sites

Showing the first 100 of 250 sites across 5 countries. Choose a country and city above to see the rest.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Jun 2026, 57 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2021
First posted
Aug 6, 2021
StartActual
Sep 14, 2021
Primary completionActual
Jun 30, 2026
CompletionEst.
Jul 1, 2027
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04994132
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
Sep 14, 2021
Primary completion
Jun 30, 2026
Completion
Jul 1, 2027 (estimated)
Last update
Jul 30, 2026

Study contacts

Wendy Allen-Rhoades
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Cyclophosphamide · Dactinomycin · Vincristine · Vinorelbine

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