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Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 396 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Trial status: Active, Not Recruiting to Completed

    Study completion date changed from estimate of Jun 30, 2028 to Mar 31, 2026; Study sites revised (185)

    Show what changed: Study sites
    Cedars-Sinai Medical Center Michigan State University VCU ClinicalMassey Center Virginia Commonwealth University/MasseyComprehensive Cancer Center

    Study Status, Oversight, Arms and Interventions, Contacts/Locations, Outcome Measures (Results)v396

  2. Minor

    Completion date: Apr 19, 2025 to Jun 30, 2028

    Study sites revised (185)

    Show what changed: Study sites
    Saint Mary's HospitalMedical Center Children's Healthcare of Atlanta - EglestonArthur M Blank Hospital AscensionHenry Ford Health Saint John Hospital

    Study Status, Contacts/Locations, Outcome Measures (Results)v395

  3. Notable

    Start date: Mar 26, 2007 to May 23, 2007

    Completion date: Jan 30, 2025 to Apr 19, 2025; Interventions: Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Filgrastim (Biological), Isotretinoin (Drug), Laboratory Biomarker Analysis… to Biospecimen Collection (Procedure), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Filgrastim (Biological), Isotretinoin…; Eligibility criteria expanded, about 122 words; and 2 more

    Show all 6 changes in this update
    • Notable Start date: Mar 26, 2007 to May 23, 2007
    • Minor Completion date: Jan 30, 2025 to Apr 19, 2025
    • Minor Interventions: Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Filgrastim (Biological), Isotretinoin (Drug), Laboratory Biomarker Analysis… to Biospecimen Collection (Procedure), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Filgrastim (Biological), Isotretinoin…
    • Minor Eligibility criteria expanded, about 122 words
      Show what changed
      Inclusion Criteria: Age greater than or equal to 3 and less than 22 years at the time of diagnosis Newly diagnosed, previously untreated: (1) M0 medulloblastom [...] mography (CT) scans are NOT sufficient for study eligibility since radiation therapy planning and response will be based on MRI scans only Post-operative head MRI scan with and without contrast (pre [...] osterior fossa tumors, pre-operative MRI scans are preferred because surgically-induced inflammation/blood can be difficult to distinguish from tumor Lumbar cerebrospinal fluid (CSF) cytology examination must [...] or a positive lumbar CSF obtained [...]
    • Minor Study description expanded, about 30 words
      Show what changed
      [...] -free survival for high risk medulloblastoma/PNET patients. SECONDARYCORRELATIVE SCIENCE OBJECTIVES: I. To compare residual disease response to radi [...] he absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, lumbar puncture and magnetic resonance imaging (MRI) throughout the study. ARM B (standard chemoradiotherapy plus carboplatin and stand [...] THERAPY: Patients receive maintenance therapy as in Arm I. Patients also undergo blood sample collection, lumbar puncture and MRI throughout the study. ARM C (standard chemoradiotherapy, standard maintenance t [...]
    • Minor Study sites revised (185)
      Show what changed
      Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital University atof SpectrumMissouri Health ColumbiaChildren's RegionalHospital NYU WinthropLangone Hospital - Long Island

    Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locationsv394

  4. Minor

    Completion date: Jan 10, 2024 to Jan 30, 2025

    Study Status, Oversightv393

  5. Minor

    Study sites: 196 to 185

    Completion date: Jul 30, 2028 to Jan 10, 2024

    Study Status, Arms and Interventions, Contacts/Locationsv392

Show 45 earlier versions

  1. Minor

    Completion date: Jun 30, 2028 to Jul 30, 2028

    Study sites revised (196)

    Show what changed: Study sites
    CardonBanner Children's Medicalat CenterDesert UCSF Benioff Children's Hospital and Research Center at Oakland UFOrlando Health Cancer Center at Orlando HealthInstitute Saint Luke's Mountain States TumorCancer Institute - Boise Ascension Saint Vincent Hospital and Health Care Center FloatingIndianapolis Hospital for Tufts Children's at Tufts Medical CenterHospital Mayo Clinic in Rochester Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Carilion Clinic Children's Hospital

    Study Status, Arms and Interventions, Contacts/Locationsv391

  2. Minor

    Study Status

    Re-verified, no change to tracked fields

    v390

  3. Notable

    Results first posted: Aug 7, 2020

    Primary endpoints revised (2); Secondary endpoints revised (16); Publications: 1 to 2

    Show what changed: Primary endpoints
    Percent Probability of Event-free survivalSurvival (EFS) percentage for patientsPatients withWith medulloblastomaMedulloblastoma Percent Probability of Event-free survivalSurvival (EFS) percentage for patientsPatients withWith supratentorialSupratentorial primitivePrimitive neuroectodermalNeuroectodermal tumorTumor (SPNET)
    Show what changed: Secondary endpoints
    Tumor responseResponse to radiationRadiation therapyTherapy for patientsPatients withWith medulloblastomaMedulloblastoma Tumor responseResponse to radiationRadiation therapyTherapy for patientsPatients withWith Supratentorial Primitive Neuroectodermal Tumor (SPNET) Percent Probability of Overall survivalSurvival (OS) percentage for patientsPatients withWith medulloblastomaMedulloblastoma Percent Probability of Overall survivalSurvival (OS) percentage for patientsPatients withWith Supratentorial Primitive Neuroectodermal Tumor (SPNET) The estimatedEstimated fullFull-scale IQ (FSIQ) at 9+/-3 mon [...] [...]
    Show what changed: Publications
    Hwang EI, Kool M, Burger PC, Capper D, Chavez L, Brabetz S, Williams-Hughes C, Billups C, Heier L, Jaju A, Michalski J, Li Y, Leary S, Zhou T, von Deimling A, Jones DTW, Fouladi M, Pollack IF, Gajjar A, Packer RJ, Pfister SM, Olson JM. Extensive Molecular and Clinical Heterogeneity in Patients With [...]

    Study Status, Outcome Measures, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv389

  4. Notable

    Primary endpoints: 1 to 2

    Completion date: Jun 30, 2028; Secondary endpoints: 8 to 16; Study sites revised (196)

    Show what changed: Primary endpoints
    Event-free survival (EFS) percentage for patients with medulloblastoma Event-free survival (EFS) percentage for patients with supratentorial primitive neuroectodermal tumor (SPNET)
    Show what changed: Secondary endpoints
    Tumor response to radiation therapy for patients with ormedulloblastoma Tumor withoutresponse carboplatinto radiation therapy for patients with SPNET Overall survival (OS) percentage for patients with medulloblastoma NeurocognitiveOverall functionsurvival as(OS) measuredpercentage byfor thepatients with SPNET The estimated full-scale IQ (FSIQ) at time9+/-3 pointmonths 1post diagnosis for medulloblastoma patients Neurocognitive function as measured by theThe estimated full-scale IQ (FSIQ) at time30+/-6 pointmonths 2post diagnosis for medulloblastoma patients Neurocognitive function as measured [...] [...]
    Show what changed: Study sites
    TheProMedica Toledo Hospital/ToledoRussell J Ebeid Children's Hospital

    Study Identification, Study Status, Oversight, Arms and Interventions, Outcome Measures, Contacts/Locationsv388

  5. Minor

    Secondary endpoints: 4 to 8

    Study title revised

    Show what changed: Secondary endpoints
    TimeOverall tosurvival death(OS) percentage Neurocognitive function as measured by the estimated full-scale IAIQ (FSIQ) at baselinetime andpoint two1 Neurocognitive followfunction upas measured by the estimated full-scale IQ (FSIQ) at time pointspoint 2 Neurocognitive function as measured by the estimated full-scale IQ (FSIQ) at time point 3 Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at baselinetime andpoint two1 Metacognition followIndex up(MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at time pointspoint 2 Metacognition Index [...]
    Show what changed: Study title
    [...] y Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

    Study Identification, Study Status, Oversight, Arms and Interventions, Outcome Measuresv387

  6. Minor

    Enrollment target: estimated 400 to confirmed 379

    Primary completion date changed from estimate of Jul 30, 2020 to Jun 30, 2019; Eligibility criteria revised; Study sites revised (196)

    Show what changed: Eligibility criteria
    [...] ampin, phenytoin, phenobarbitol, carbamazepine, and St. John?'s wort; the use of these drugs should be avoided with vincri [...]
    Show what changed: Study sites
    LosLundquist AngelesInstitute for Biomedical Research InstituteInnovation at Harbor-UCLA Medical Center UniversityUMC MedicalCancer Center / UMC Health System

    Study Identification, Study Status, Oversight, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations, Referencesv386

  7. Minor

    Study Status, References

    Re-verified, no change to tracked fields

    v385

  8. Minor

    Secondary endpoints: 2 to 4

    Show what changed: Secondary endpoints
    Neurocognitive function as measured by the estimated full-scale IA (FSIQ) at baseline and two follow up time points Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at baseline and two follow up time points

    Study Status, Oversight, Outcome Measuresv384

  9. Notable

    Trial status: Suspended to Active, Not Recruiting

    Primary completion date: Jun 30, 2019 to Jul 30, 2020; Study sites: 197 to 196

    Study Status, Oversight, Arms and Interventions, Contacts/Locationsv383

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v382

  11. Stopped

    Trial status: Recruiting to Suspended

    Sponsor's reason: Temporarily stopped for assessment. Contact ctsucontact@westat.com for specifics

    Primary completion date: Jun 2018 to Jun 30, 2019; Study sites: 186 to 197; Start date: Mar 2007 to Mar 26, 2007; and 2 more

    Show all 6 changes in this update
    • Stopped Trial status: Recruiting to Suspended
    • Notable Primary completion date: Jun 2018 to Jun 30, 2019
    • Minor Study sites: 186 to 197
    • Minor Start date: Mar 2007 to Mar 26, 2007
    • Minor Eligibility criteria shortened, about 78 words
      Show what changed
      [...] ncy > 8 weeks No previous chemotherapy or radiation therapy Patients taking Accutane (isotretinoin) for acne must discontinue drug use with this indication prior to enrollment; corticosteroidsCorticosteroids should not be used during chemotherapy administration as an antiemetic Isotretinoin is contraindicated in patients with parabens allergy and patients with soybean allergy; concurrent use with tetracyclines should be avoided; intake of vitamin A should be limited for the duration of isotretinoin treatment Selected strong inhibitors of cytochrome P450, family 3, su [...] ampin, phenytoin, phenobarb [...]
    • Minor Study description expanded, about 20 words
      Show what changed
      [...] elated quality of life. OUTLINE: Patients are randomized to 1Arm A or Arm B (Arms C and D closed to accrual as of 4Amendment treatment3 arms1/27/15). ARM IA (standard chemoradiotherapy and standard maintenance therap [...] bsence of disease progression or unacceptable toxicity. ARM IIB (standard chemoradiotherapy plus carboplatin and standard m [...] RAPY: Patients receive maintenance therapy as in Arm I. ARM IIIC (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 1/27/15): CHEMORADIOTHERAPY: Patients undergo chemoradio [...] [...]

    Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locationsv381

  12. Minor

    Study Status

    Re-verified, no change to tracked fields

    v380

  13. Notable

    Trial status: Suspended to Recruiting

    Study sites: 170 to 186

    Study Status, Contacts/Locationsv379

  14. Notable

    Primary completion date: Nov 2015 to Jun 2018

    Study Statusv378

  15. Stopped

    Trial status: Recruiting to Suspended

    Sponsor's reason: Temporarily stopped for assessment

    Interventions: carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), filgrastim (Biological), isotretinoin (Drug), laboratory biomarker analysis… to Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Filgrastim (Biological), Isotretinoin (Drug), Laboratory Biomarker Analysis…; Study sites revised (170)

    Show what changed: Study sites
    UniversityMiller ofChildren's Alabamaand atWomen's BirminghamHospital Long Beach University of ArkansasCalifornia Davis Comprehensive Cancer Center UCSF Medical Center-Mission Bay Golisano Children's Hospital of Southwest Florida Nemours Children's Clinic-Jacksonville South Miami Children's Hospital Florida Hospital Orlando Arnold Palmer Hospital for Children Nemours Children's Hospital Kapiolani Medical SciencesCenter for Women and Children MillerUniversity of Chicago Comprehensive Cancer Center Advocate Children's Hospital-Park Ridge University of Kentucky/Markey Cancer Center Children's Hos [...] [...]

    Study Identification, Study Status, Arms and Interventions, Contacts/Locationsv377

  16. Notable

    Primary completion date: Sep 2013 to Nov 2015

    Primary endpoint revised; Enrollment target: 380 to 400; Study sites: 169 to 170; and 5 more

    Show all 9 changes in this update
    • Notable Primary completion date: Sep 2013 to Nov 2015
    • Notable Primary endpoint revised
      Show what changed
      Event-free survival (EFS) percentage
    • Minor Enrollment target: 380 to 400
    • Minor Study sites: 169 to 170
    • Minor Interventions: carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), filgrastim (Biological), isotretinoin (Drug), laboratory biomarker analysis… to carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), filgrastim (Biological), isotretinoin (Drug), laboratory biomarker analysis…
    • Minor Eligibility criteria expanded, about 441 words
      Show what changed
      Inclusion Criteria: Histologically confirmed diagnosis of medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET) Newly diagnosed, disease Previouslypreviously untreated: disease Meets(1) 1 of the following criteria: M0 medulloblastoma with > 1.5 cm²cm^2 residual; tumor (2) M+ medulloblastoma M0; orpatients M+with supratentorial PNET (including pineoblastoma) Diffuselydiffusely anaplastic medulloblastoma withare anyeligible regardless of M-stage or residual tumor Must have undergone stereotactic biopsy or attempted neurosurgical resectionAs of theamendment tumor# within2, thee [...] [...]
    • Minor Secondary endpoints revised (2)
      Show what changed
      Tumor response to radiotherapyradiation (RT)therapy with or without carboplatin using width (W), transverse (T), and length (L) measurements
    • Minor Study description shortened, about 23 words
      Show what changed
      PRIMARY OBJECTIVES: I. DetermineTo determine whether carboplatin radiosensitization increases long- term, event-free survival of pediatric patients with newly diagnosed, previously untreated,for high- risk medulloblastoma or supratentorial /primitive neuroectodermal tumorstumor (PNET) patients. II. To Determinedetermine whether isotretinoin increases long- term, event-free survival offor thesehigh risk medulloblastoma/PNET patients. SECONDARY OBJECTIVES: I. CompareTo compare residual disease response to radiotherapyradiation alone versus radiotherapyradiation andplus carboplatin in these patie [...] [...]
    • Minor Study title shortened, about 5 words
      Show what changed
      [...] y Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor

    Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv376

  17. Notable

    Trial status: Suspended to Recruiting

    Enrollment target: 300 to 380; Study sites: 160 to 169

    Study Status, Study Design, Contacts/Locationsv375

  18. Notable

    Primary completion date: Dec 2012 to Sep 2013

    Primary endpoint revised; Enrollment target: 290 to 300; Secondary endpoints: details revised at 2 of 2 entries

    Show what changed: Primary endpoints
    Event-free survival (EFS) percentage

    Study Status, Study Design, Outcome Measuresv374

  19. Minor

    Study Status, Arms and Interventions, Contacts/Locations

    Re-verified, no change to tracked fields

    v373

  20. Stopped

    Trial status: Recruiting to Suspended

    Sponsor's reason: Temporarily Closed to Accrual

    Enrollment target: estimated 300 to confirmed 290; Study sites: 168 to 160; Primary completion date changed from estimate of Dec 2013 to Dec 2012

    Study Identification, Study Status, Study Design, Contacts/Locationsv372

  21. Notable

    Primary completion date: Nov 2015 to Dec 2013

    Primary endpoint revised; Study sites: 160 to 168; Interventions: carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), filgrastim (Biological), isotretinoin (Drug), radiation therapy (Radiation)… to carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), filgrastim (Biological), isotretinoin (Drug), laboratory biomarker analysis…; and 3 more

    Show all 7 changes in this update
    • Notable Primary completion date: Nov 2015 to Dec 2013
    • Notable Primary endpoint revised
      Show what changed
      Event-free survival (e.g.,EFS) events comprising disease progression or recurrence, occurrence of a second malignant neoplasm, or death from any cause)percentage
    • Minor Study sites: 160 to 168
    • Minor Interventions: carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), filgrastim (Biological), isotretinoin (Drug), radiation therapy (Radiation)… to carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), filgrastim (Biological), isotretinoin (Drug), laboratory biomarker analysis…
    • Minor Eligibility criteria shortened, about 96 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: Histologically confirmed diagnosis of medulloblastoma or s [...] obtained pre-operatively or within 31 days after surgery*** NOTE: **Not required for patients with M2 or M3 disease or for patients who undergo stereotactic biopsy only NOTE: ***If a spinal tap is contraindicated, and there is no ventricular CSF available, CSF cytology may be waived for patients with supratentorial tumors OR if there is documentation of spinal subarachnoid metastases (M3); patients with M1 disease must have either an intraoperative-positive CSF by [...] No M4 disease PATIENT CHARACTE [...] [...]
    • Minor Secondary endpoints revised (2)
      Show what changed
      Residual tumorTumor response to radiotherapy (RT) with or without carboplatin using width (W), transverse (T), and length (L) measurements
    • Minor Study description shortened, about 9 words
      Show what changed
      PRIMARY OBJECTIVES: Primary I. Determine whether carboplatin radiosensitization increases l [...] lastoma or supratentorial primitive neuroectodermal tumors. II. Determine whether isotretinoin increases long-term, event-free survival of these patients. SecondarySECONDARY OBJECTIVES: I. Compare residual disease response to radiotherapy alone versus radiotherapy and carboplatin in these patients. II. Identify molecular prognostic indicators suitable for patien [...] lastoma). Patients are randomized to 1 of 4 treatment arms. ArmARM I (standard chemoradiotherapy and standard maintenance therapy): Chemoradiothe [...] [...]

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv371

  22. Minor

    Study Status

    Re-verified, no change to tracked fields

    v370

  23. Minor

    Site contacts updated at 1 of 160 sites

    Study Status, Contacts/Locationsv369

  24. Minor

    Site contacts updated at 1 of 160 sites

    Study Status, Contacts/Locationsv368

  25. Minor

    Study Status

    Re-verified, no change to tracked fields

    v367

  26. Minor

    Study sites revised (160)

    Show what changed: Study sites
    OverlookCarol G. Simon Cancer Center at Morristown Memorial Hospital

    Study Status, Contacts/Locationsv366

  27. Minor

    Site contacts updated at 1 of 160 sites

    Study Status, Contacts/Locationsv365

  28. Minor

    Site contacts updated at 1 of 160 sites

    Study Status, Contacts/Locationsv364

  29. Notable

    Primary completion date: Dec 2012 to Nov 2015

    Study sites revised (160)

    Show what changed: Study sites
    GreenvilleBI-LO HospitalCharities Children's Cancer Center

    Study Status, Contacts/Locationsv363

  30. Minor

    Site details revised at 1 of 160 sites

    Study Status, Contacts/Locationsv362

  31. Minor

    Site contacts updated at 1 of 160 sites

    Study Status, Contacts/Locationsv361

  32. Minor

    Study sites: 159 to 160

    Study Status, Contacts/Locationsv360

  33. Minor

    Site contacts updated at 1 of 159 sites

    Study Status, Contacts/Locationsv359

  34. Minor

    Site contacts updated at 1 of 159 sites

    Study Status, Contacts/Locationsv358

  35. Minor

    Study sites: 158 to 159

    Study Status, Contacts/Locationsv357

  36. Minor

    Site contacts updated at 1 of 158 sites

    Study Status, Contacts/Locationsv356

  37. Minor

    Site details revised at 1 of 158 sites

    Study Status, Contacts/Locationsv355

  38. Minor

    Site contacts updated at 1 of 158 sites

    Study Status, Contacts/Locationsv354

  39. Minor

    Site contacts updated at 1 of 158 sites

    Study Status, Contacts/Locationsv353

  40. Minor

    Study sites: 157 to 158

    Study Status, Contacts/Locationsv352

  41. Minor

    Site contacts updated at 1 of 157 sites

    Study Status, Contacts/Locationsv351

  42. Minor

    Site contacts updated at 1 of 157 sites

    Study Status, Contacts/Locationsv350

  43. Minor

    Site contacts updated at 1 of 157 sites

    Study Status, Contacts/Locationsv349

  44. Minor

    Study sites: 156 to 157

    Study Status, Contacts/Locationsv348

  45. Minor

    Study sites: 157 to 156

    Study Status, Contacts/Locationsv347

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Chemotherapy drugs, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
Trial Details
NCT Number NCT00392327
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Anaplastic Medulloblastoma, Medulloblastoma
Enrollment 379 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov