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

StatusCompleted
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

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

  1. 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)
    v396
  2. Study completion date: Apr 19, 2025 to Jun 30, 2028
    • Study sites revised (185)
    v395
  3. Start date: Mar 26, 2007 to May 23, 2007v394 Show 5 more changesShow less
    • Study 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
    • Study description expanded, about 30 words
    • Study sites revised (185)
  4. Study completion date: Jan 10, 2024 to Jan 30, 2025v393
  5. Study sites: 196 to 185
    • Study completion date: Jul 30, 2028 to Jan 10, 2024
    v392
Show 45 earlier versionsHide 45 earlier versions
  1. Study completion date: Jun 30, 2028 to Jul 30, 2028
    • Study sites revised (196)
    v391
  2. Re-verified, no change to tracked fieldsv390
  3. Results first posted: Aug 7, 2020
    • Primary endpoints revised (2)
    • Secondary endpoints revised (16)
    • Publications: 1 to 2
    v389
  4. Primary endpoints: 1 to 2
    • Study completion date: Jun 30, 2028
    • Secondary endpoints: 8 to 16
    • Study sites revised (196)
    v388
  5. Secondary endpoints: 4 to 8
    • Study title revised
    v387
  6. 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)
    v386
  7. Re-verified, no change to tracked fieldsv385
  8. Secondary endpoints: 2 to 4v384
  9. Trial status: Suspended to Active, Not Recruiting
    • Primary completion date: Jun 30, 2019 to Jul 30, 2020
    • Study sites: 197 to 196
    v383
  10. Re-verified, no change to tracked fieldsv382
  11. Trial status: Recruiting to Suspended Sponsor's reason: Temporarily stopped for assessment. Contact ctsucontact@westat.com for specificsv381 Show 5 more changesShow less
    • Primary completion date: Jun 2018 to Jun 30, 2019
    • Study sites: 186 to 197
    • Start date: Mar 2007 to Mar 26, 2007
    • Eligibility criteria shortened, about 78 words
    • Study description expanded, about 20 words
  12. Re-verified, no change to tracked fieldsv380
  13. Trial status: Suspended to Recruiting
    • Study sites: 170 to 186
    v379
  14. Primary completion date: Nov 2015 to Jun 2018v378
  15. 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)
    v377
  16. Primary completion date: Sep 2013 to Nov 2015v376 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 380 to 400
    • Study sites: 169 to 170
    • 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…
    • Eligibility criteria expanded, about 441 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 23 words
    • Study title shortened, about 5 words
  17. Trial status: Suspended to Recruiting
    • Enrollment target: 300 to 380
    • Study sites: 160 to 169
    v375
  18. 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
    v374
  19. Re-verified, no change to tracked fieldsv373
  20. 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
    v372
  21. Primary completion date: Nov 2015 to Dec 2013v371 Show 6 more changesShow less
    • 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…
    • Eligibility criteria shortened, about 96 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 9 words
  22. Re-verified, no change to tracked fieldsv370
  23. Site contacts updated at 1 of 160 sitesv369
  24. Site contacts updated at 1 of 160 sitesv368
  25. Re-verified, no change to tracked fieldsv367
  26. Study sites revised (160)v366
  27. Site contacts updated at 1 of 160 sitesv365
  28. Site contacts updated at 1 of 160 sitesv364
  29. Primary completion date: Dec 2012 to Nov 2015
    • Study sites revised (160)
    v363
  30. Site details revised at 1 of 160 sitesv362
  31. Site contacts updated at 1 of 160 sitesv361
  32. Study sites: 159 to 160v360
  33. Site contacts updated at 1 of 159 sitesv359
  34. Site contacts updated at 1 of 159 sitesv358
  35. Study sites: 158 to 159v357
  36. Site contacts updated at 1 of 158 sitesv356
  37. Site details revised at 1 of 158 sitesv355
  38. Site contacts updated at 1 of 158 sitesv354
  39. Site contacts updated at 1 of 158 sitesv353
  40. Study sites: 157 to 158v352
  41. Site contacts updated at 1 of 157 sitesv351
  42. Site contacts updated at 1 of 157 sitesv350
  43. Site contacts updated at 1 of 157 sitesv349
  44. Study sites: 156 to 157v348
  45. Study sites: 157 to 156v347
  • 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.
Children's Oncology Group
95 trials monitored
See 5 trials at risk
Glioma
1,259 trials monitored
See 92 trials at risk
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
(from sponsor)		 Anaplastic Medulloblastoma, Medulloblastoma
Related terms Medulloblastoma
Enrollment 379 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov