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Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 415 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Study sites revised (197)

    Show what changed: Study sites
    Cedars-Sinai Medical Center University of FloridaUF Health ScienceCancer CenterInstitute - Gainesville Saint Mary's HospitalMedical Center Michigan State University VCU ClinicalMassey Center Virginia Commonwealth University/MasseyComprehensive Cancer Center

    Study Identification, Study Status, Contacts/Locationsv415

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Completion date: Dec 31, 2024; Study sites revised (197)

    Show what changed: Study sites
    AscensionHenry Ford Health Saint John Hospital

    Study Status, Contacts/Locationsv414

  3. Minor

    Study sites: 178 to 197

    Start date: Apr 2004 to Apr 30, 2004; Study description expanded, about 324 words

    Show what changed: Study description
    PRIMARY OBJECTIVESOBJECTIVE: I. CompareTo determine whether reducing the craniospinal dose of radiation therapy to 18.00 Gy in children 3-7 years of age does not compromise event-free survival (EFS)and overall survival as compared to treatment with 23.40 Gy of pediatriccraniospinal patientsradiation; (3and to 7determine yearsif reducing the irradiated volume of age)the withprimary newlysite diagnosedtumor standard-riskboost medulloblastomafrom treatedthe with standard-dose versus (vs.) reduced-dose craniospinal radiotherapy (SDCSI vs. LDCSI). II. Compare EFS of patients (3-21 years of age) tre [...] [...]

    Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Contacts/Locations, IPDSharing, Referencesv413

  4. Minor

    5 amendments

    5 re-verifications since 2020-01-28, no change to tracked fields

    v408-v412

  5. Notable

    Primary endpoints: 1 to 2

    Trial status: Completed to Active, Not Recruiting; Primary completion date: Mar 2016 to Mar 31, 2016; Completion date: Mar 2016 to not stated; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoints: 1 to 2
      Show what changed
      Overall Survival (OS)
    • Minor Trial status: Completed to Active, Not Recruiting
    • Minor Primary completion date: Mar 2016 to Mar 31, 2016
    • Minor Completion date: Mar 2016 to not stated
    • Minor Secondary endpoints: 12 to 18
      Show what changed
      Overall Survival (OS) Post-treatment Endocrine Function as Measured by Thyroid Stimulating Hormone (TSH) by CSI Group Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v4Version (v)4 Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) andby AlsoCSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis). Post-treatment Neurocognitive Function as Measured by the MetacognitionEstimated IndexFull-scale IQ (MIFSIQ) onby CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis) Post-treatment Neuroc [...] [...]

    Study Status, Outcome Measures, Outcome Measures (Results)v407

Show 41 earlier versions

  1. Minor

    Secondary endpoints revised (12)

    Show what changed: Secondary endpoints
    Post-treatment Endocrine Function (Growthas HormoneMeasured (GH) andby Thyroid Stimulating Hormone (TSH) as Measured by LaboratoryCSI Assessment)Group Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation TestTests at the Time of Completion of Therapy. by RT Group Time to Death From Any Cause / Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays Time to Recurrence, Progression or Death Due to Cancer / Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays

    Study Status, Outcome Measures, Outcome Measures (Results)v406

  2. Notable

    Results first posted: Jun 14, 2017

    Secondary endpoints revised (12); Primary endpoint revised; Site details revised at 1 of 178 sites

    Show what changed: Secondary endpoints
    TimeOverall to death from any cause / overall survivalSurvival (OS) Local posteriorPosterior fossaFossa (LPF) failureFailure rateRate Non-local posteriorPosterior fossaFossa (NLPF) failureFailure rateRate Non-posterior fossaFossa (NPF) failureFailure rateRate Post-treatment endocrineEndocrine functionFunction (growthGrowth hormoneHormone (GH) and thyroidThyroid stimulatingStimulating hormoneHormone (TSH)) as measuredMeasured by laboratoryLaboratory assessmentAssessment) . Post-treatment gradeGrade 3+ hearingHearing lossLoss as measuredMeasured by CTCAE v4 Post-treatment neurocognitiveNeurocogn [...] [...]
    Show what changed: Primary endpoints
    Event-free survivalSurvival (EFS)

    Study Status, Outcome Measures, Contacts/Locations, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv405

  3. Notable

    Primary endpoint revised

    Enrollment target: 528 to 549; Completion date: Mar 2016; Secondary endpoints: 9 to 12; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      Time to eventEvent-free survival (EFS)
    • Minor Enrollment target: 528 to 549
    • Minor Completion date: Mar 2016
    • Minor Secondary endpoints: 9 to 12
      Show what changed
      IncidenceTime ofto gradedeath 3 and grade 4 toxicities infrom any bodycause system/ asoverall assessedsurvival by the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0(OS) Local posterior fossa (LPF) failure rate Non-local posterior fossa (NLPF) failure rate Non-posterior fossa (NPF) failure rate Post-treatment endocrine function (e.g.,growth growth,hormone sexual maturation,(GH) and needthyroid forstimulating hormone replacement(TSH)) as measured by laboratory assessment,) clinical history, and exam. Post-treatment grade 3+ hearing loss as measuremeasured by audio [...] [...]
    • Minor Study description expanded, about 88 words
      Show what changed
      PRIMARY OBJECTIVES: I. Compare event-free andsurvival overall survival(EFS) of pediatric patients (3 to 7 years of age) with newly diag [...] s.) reduced-dose craniospinal radiotherapy (SDCSI vs. LDCSI) and posterior fossa boost vs tumor bed boost radiotherapy (PFRT vs. IFRT) in combination with chemotherapy comprising vincristine, cisplatin, lomustine, and cyclophosphamide. II. Compare event-free and overall survivalEFS of these patients (8 to 3-21 years of age) treated with standard-dose craniospinal rad [...] this chemotherapy regimen. SECONDARY OBJECTIVES: I. Compare overall survival (OS) of pediatric [...] [...]

    Study Status, Study Description, Study Design, Outcome Measuresv404

  4. Notable

    Primary endpoint revised

    Trial status: Active, Not Recruiting to Completed; Enrollment target: 549 to 528; Study sites: 182 to 178; and 5 more

    Show all 9 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      EventTime to event-free survival (EFS)
    • Minor Trial status: Active, Not Recruiting to Completed
    • Minor Enrollment target: 549 to 528
    • Minor Study sites: 182 to 178
    • Minor Interventions: cisplatin (Drug), cyclophosphamide (Drug), lomustine (Drug), radiation therapy (Radiation), vincristine sulfate (Drug) to Cisplatin (Drug), Craniospinal Irradiation (Radiation), Cyclophosphamide (Drug), Involved-Field Radiation Therapy (Radiation), Laboratory…
    • Minor Eligibility criteria expanded, about 61 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: Histologically confirmed medulloblastoma located in the po [...] but before study enrollment Brain stem involvement allowed PATIENT CHARACTERISTICS: Age 3 to 21 at diagnosis Performance status - Karnofsky 50-100% (> 16 years of age) Performance OR status - Lansky 30-100% (≤ 16 years of age) Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,500/mm^3uL Platelet count > 100,000/mm^3uL (transfusion independent) Hemoglobin > 10 g/dL (transfusions allowed) Hepatic Bilirubin < 1.5 times upper limit of normal (ULN) for age AST or ALT < 1.5 ti [...] [...]
    • Minor Secondary endpoints: 10 to 9
      Show what changed
      Quality of Life as measured by Pediatric Quality of Life Inventory (PedsQL), Behavior Assessment System for Children (BASC), Behavior Rating Inventory of Executive Function (BRIEF), and Adaptive Behavior Assessment System (ABAS) at 3 years
    • Minor Study description expanded, about 10 words
      Show what changed
      PRIMARY OBJECTIVES: Primary I. Compare event-free and overall survival of pediatric patient [...] ed standard-risk medulloblastoma treated with standard-dose versus (vs.) reduced-dose craniospinal radiotherapy (SDCSI vs. LDCSI) and posterior fossa boost vs tumor bed boost radiotherapy (PFRT vs. IFRT) in combination with chemotherapy comprising vincristine, cisplatin, lomustine, and cyclophosphamide. II. Compare event-free and overall survival of these patients (8 [...] radiotherapy in combination with this chemotherapy regimen. SecondarySECONDARY OBJECTIVES: I. Compare patterns of failure in patients treate [...] [...]
    • Minor Study arms: 8 to 6

    Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv403

  5. Minor

    Study sites: 184 to 182

    Study Status, Contacts/Locationsv402

  6. Minor

    Primary completion date: Dec 2015 to Mar 2016

    Study Statusv401

  7. Minor

    Primary completion date changed from estimate of Jun 2016 to Dec 2015

    Study Statusv400

  8. Minor

    Primary completion date: Dec 2015 to Jun 2016

    Study Statusv399

  9. Minor

    Primary completion date: Jul 2016 to Dec 2015

    Study Statusv398

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v397

  11. Notable

    Primary endpoint revised

    Trial status: Recruiting to Active, Not Recruiting; Enrollment target: estimated 510 to confirmed 549; Secondary endpoints: details revised at 8 of 10 entries; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      Time to eventEvent-free survival (EFS)
    • Minor Trial status: Recruiting to Active, Not Recruiting
    • Minor Enrollment target: estimated 510 to confirmed 549
    • Minor Secondary endpoints: details revised at 8 of 10 entries
    • Minor Site details revised at 184 of 184 sites

    Study Status, Study Design, Outcome Measures, Contacts/Locationsv396

  12. Minor

    Study Status

    Re-verified, no change to tracked fields

    v395

  13. Notable

    Primary endpoint revised

    Secondary endpoints: 9 to 10; Site details revised at 11 of 184 sites; Study arms: 6 to 8

    Show what changed: Primary endpoints
    Time to event-free assurvival measured by the time to disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm at 3 years(EFS)
    Show what changed: Secondary endpoints
    Time to recurrence, progression, or death due to cancer at 3 years Time to death atfrom 3any yearscause Local Posteriorposterior Fossafossa (LPF) Failure as determined by tumor recurrence or progression within the tumor bed at 3 yearsfailure Non-local Posteriorposterior Fossafossa (NLPF) Failure as determined by recurrence outside CTVboost but within CTVPF at 3 yearsfailure Non-Posteriorposterior Fossafossa (NPF) Failure as determine by recurrence within the neuroaxis but outside of CTVPF at 3 yearsfailure Post-treatment neurocognitive function as measured by Neuropsychometricneuropsychometric [...]

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv394

  14. Minor

    Site details revised at 1 of 184 sites

    Study Status, Contacts/Locationsv393

  15. Minor

    Study sites: 185 to 184

    Study Status, Contacts/Locationsv392

  16. Minor

    Study sites revised (185)

    Show what changed: Study sites
    UABChildren's ComprehensiveHospital Cancerof CenterAlabama at University of Alabama at Birmingham

    Study Status, Contacts/Locationsv391

  17. Minor

    Study Status

    Re-verified, no change to tracked fields

    v390

  18. Notable

    Trial status: Suspended to Recruiting

    Study sites: 190 to 185

    Study Status, Contacts/Locationsv389

  19. Minor

    2 amendments

    2 re-verifications since 2012-09-12, no change to tracked fields

    v387-v388

  20. Stopped

    Trial status: Recruiting to Suspended

    Primary completion date: Mar 2009 to Jul 2016; Study sites: 191 to 190

    Study Status, Contacts/Locationsv386

  21. Minor

    Site contacts updated at 1 of 191 sites

    Study Status, Contacts/Locationsv385

  22. Minor

    Study Status

    Re-verified, no change to tracked fields

    v384

  23. Minor

    Site contacts updated at 1 of 191 sites

    Study Status, Contacts/Locationsv383

  24. Minor

    Study sites: 192 to 191

    Study Status, Contacts/Locationsv382

  25. Minor

    Study Status

    Re-verified, no change to tracked fields

    v381

  26. Minor

    Enrollment target: 455 to 510

    Study description expanded, about 3 words

    Show what changed: Study description
    [...] sease progression or unacceptable toxicity. Quality of life and neurocognitive function areis assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

    Study Status, Study Description, Study Designv380

  27. Minor

    Study sites revised (192)

    Show what changed: Study sites
    SacredNemours HeartChildren's CancerClinic Center- atPensacola Helen SacredDeVos Heart Hospital ButterworthChildren's Hospital at Spectrum Health

    Study Status, Contacts/Locationsv379

  28. Minor

    Study Status

    Re-verified, no change to tracked fields

    v378

  29. Minor

    Site contacts updated at 1 of 192 sites

    Study Status, Contacts/Locationsv377

  30. Minor

    Study Status

    Re-verified, no change to tracked fields

    v376

  31. Minor

    Site contacts updated at 1 of 192 sites

    Study Status, Contacts/Locationsv375

  32. Minor

    2 amendments

    2 re-verifications since 2010-12-30, no change to tracked fields

    v373-v374

  33. Minor

    Study sites revised (192)

    Show what changed: Study sites
    CaroleConnecticut andChildren's Ray Neag Comprehensive CancerMedical Center at the University of Connecticut Health Center

    Study Status, Contacts/Locationsv372

  34. Minor

    Study Status

    Re-verified, no change to tracked fields

    v371

  35. Minor

    Study sites: 179 to 192

    Study Status, Contacts/Locationsv370

  36. Minor

    Study sites revised (179)

    Show what changed: Study sites
    Children's Hospital of Pittsburgh of UPMC

    Study Status, Contacts/Locationsv369

  37. Minor

    Study Status

    Re-verified, no change to tracked fields

    v368

  38. Minor

    Study sites revised (179)

    Show what changed: Study sites
    Dayton Children's Medical Center - Dayton

    Study Status, Contacts/Locationsv367

  39. Minor

    Study Status

    Re-verified, no change to tracked fields

    v366

  • 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 randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.
Trial Details
NCT Number NCT00085735
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Medulloblastoma
Enrollment 549 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov