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

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 415 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (197)v415
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date: Dec 31, 2024
    • Study sites revised (197)
    v414
  3. Study sites: 178 to 197
    • Start date: Apr 2004 to Apr 30, 2004
    • Study description expanded, about 324 words
    v413
  4. 5 versions Re-verified since Jan 28, 2020, no change to tracked fieldsv408-v412
  5. Primary endpoints: 1 to 2v407 Show 4 more changesShow less
    • Trial status: Completed to Active, Not Recruiting
    • Primary completion date: Mar 2016 to Mar 31, 2016
    • Study completion date: Mar 2016 to not stated
    • Secondary endpoints: 12 to 18
Show 41 earlier versionsHide 41 earlier versions
  1. Secondary endpoints revised (12)v406
  2. Results first posted: Jun 14, 2017
    • Secondary endpoints revised (12)
    • Primary endpoint revised
    • Site details revised at 1 of 178 sites
    v405
  3. Primary endpoint revisedv404 Show 4 more changesShow less
    • Enrollment target: 528 to 549
    • Study completion date: Mar 2016
    • Secondary endpoints: 9 to 12
    • Study description expanded, about 88 words
  4. Primary endpoint revisedv403 Show 8 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: 549 to 528
    • Study sites: 182 to 178
    • 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…
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: 10 to 9
    • Study description expanded, about 10 words
    • Study arms: 8 to 6
  5. Study sites: 184 to 182v402
  6. Primary completion date: Dec 2015 to Mar 2016v401
  7. Primary completion date changed from estimate of Jun 2016 to Dec 2015v400
  8. Primary completion date: Dec 2015 to Jun 2016v399
  9. Primary completion date: Jul 2016 to Dec 2015v398
  10. Re-verified, no change to tracked fieldsv397
  11. Primary endpoint revisedv396 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 510 to confirmed 549
    • Secondary endpoints: details revised at 8 of 10 entries
    • Site details revised at 184 of 184 sites
  12. Re-verified, no change to tracked fieldsv395
  13. Primary endpoint revised
    • Secondary endpoints: 9 to 10
    • Site details revised at 11 of 184 sites
    • Study arms: 6 to 8
    v394
  14. Site details revised at 1 of 184 sitesv393
  15. Study sites: 185 to 184v392
  16. Study sites revised (185)v391
  17. Re-verified, no change to tracked fieldsv390
  18. Trial status: Suspended to Recruiting
    • Study sites: 190 to 185
    v389
  19. 2 versions Re-verified since Sep 12, 2012, no change to tracked fieldsv387-v388
  20. Trial status: Recruiting to Suspended
    • Primary completion date: Mar 2009 to Jul 2016
    • Study sites: 191 to 190
    v386
  21. Site contacts updated at 1 of 191 sitesv385
  22. Re-verified, no change to tracked fieldsv384
  23. Site contacts updated at 1 of 191 sitesv383
  24. Study sites: 192 to 191v382
  25. Re-verified, no change to tracked fieldsv381
  26. Enrollment target: 455 to 510
    • Study description expanded, about 3 words
    v380
  27. Study sites revised (192)v379
  28. Re-verified, no change to tracked fieldsv378
  29. Site contacts updated at 1 of 192 sitesv377
  30. Re-verified, no change to tracked fieldsv376
  31. Site contacts updated at 1 of 192 sitesv375
  32. 2 versions Re-verified since Dec 30, 2010, no change to tracked fieldsv373-v374
  33. Study sites revised (192)v372
  34. Re-verified, no change to tracked fieldsv371
  35. Study sites: 179 to 192v370
  36. Study sites revised (179)v369
  37. Re-verified, no change to tracked fieldsv368
  38. Study sites revised (179)v367
  39. Re-verified, no change to tracked fieldsv366
  • 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
1,260 trials monitored
See 93 trials at risk
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
(from sponsor)		 Medulloblastoma
Related terms Medulloblastoma
Enrollment 549 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov