Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 265 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (227)v265
  2. Trial completed
    • Study completion moved earlier from Nov 18, 2026 to Mar 31, 2026
    • Study sites revised (227)
    v264
  3. Start date: Feb 26, 2007 to Apr 30, 2007v263 Show 4 more changesShow less
    • Study completion date: Mar 31, 2026 to Nov 18, 2026
    • Eligibility criteria expanded, about 109 words
    • Study description expanded, about 34 words
    • Study sites revised (227)
  4. Study completion date: Sep 30, 2025 to Mar 31, 2026v262
  5. Study completion date: Sep 30, 2025
    • Study sites revised (227)
    v261
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (227)v260
  2. Study sites: 207 to 227
    • Interventions: 3-dimensional conformal radiation therapy (Radiation), conventional surgery (Procedure), cyclophosphamide (Drug), dactinomycin… to 3-Dimensional Conformal Radiation Therapy (Radiation), Conventional Surgery (Procedure), Cyclophosphamide (Drug), Dactinomycin…
    • Study description shortened, about 25 words
    • Study arms: 5 to 1
    v259
  3. 2 versions Re-verified since Mar 23, 2021, no change to tracked fieldsv257-v258
  4. Primary completion date: Oct 2015 to Jun 30, 2016
    • Trial status: Completed to Active, Not Recruiting
    • Start date: Feb 2007 to Feb 26, 2007
    v256
  5. Re-verified, no change to tracked fieldsv255
  6. Results first posted: Jun 14, 2017
    • Primary endpoints revised (3)
    • Trial status: Active, Not Recruiting to Completed
    • Secondary endpoint revised
    v254
  7. Study arms: 1 to 5v253
  8. Primary completion date changed from estimate of Jul 2016 to Oct 2015v252
  9. 2 versions Re-verified since Oct 9, 2014, no change to tracked fieldsv250-v251
  10. Primary endpoints revised (3)
    • Study description expanded, about 25 words
    v249
  11. Re-verified, no change to tracked fieldsv248
  12. Primary endpoints: 1 to 3v247 Show 9 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 400 to confirmed 395
    • Study sites: 201 to 207
    • Interventions: cyclophosphamide (Drug), dactinomycin (Biological), doxorubicin hydrochloride (Drug), etoposide (Drug), radiation therapy (Radiation)… to 3-dimensional conformal radiation therapy (Radiation), conventional surgery (Procedure), cyclophosphamide (Drug), dactinomycin…
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints expanded, about 18 words
    • Study description shortened, about 9 words
    • Study title revised
    • Study arms: 0 to 1
  13. Re-verified, no change to tracked fieldsv246
  14. Site contacts updated at 1 of 201 sitesv245
  15. Study sites: 200 to 201v244
  16. Site contacts updated at 1 of 200 sitesv243
  17. Study sites: 199 to 200v242
  18. Study sites revised (199)v241
  19. Site contacts updated at 1 of 199 sitesv240
  20. Site contacts updated at 1 of 199 sitesv239
  21. Primary completion date: Jan 2012 to Jul 2016
    • Study sites: 195 to 199
    v238
  22. Site contacts updated at 1 of 195 sitesv237
  23. Re-verified, no change to tracked fieldsv236
  24. Study sites: 194 to 195v235
  25. Study sites: 193 to 194v234
  26. Study sites revised (193)v233
  27. Site details revised at 2 of 193 sitesv232
  28. Site details revised at 1 of 193 sitesv231
  29. Site details revised at 3 of 193 sitesv230
  30. Site details revised at 1 of 193 sitesv229
  31. Site details revised at 1 of 193 sitesv228
  32. Site details revised at 1 of 193 sitesv227
  33. Site contacts updated at 1 of 193 sitesv226
  34. Re-verified, no change to tracked fieldsv225
  35. Study sites revised (193)v224
  36. Study sites revised (193)v223
  37. Study sites: 192 to 193v222
  38. Re-verified, no change to tracked fieldsv221
  39. Enrollment target: 295 to 400v220 Show 4 more changesShow less
    • Interventions: conventional surgery (Procedure), cyclophosphamide (Drug), dactinomycin (Biological), doxorubicin hydrochloride (Drug), etoposide (Drug)… to cyclophosphamide (Drug), dactinomycin (Biological), doxorubicin hydrochloride (Drug), etoposide (Drug), radiation therapy (Radiation)…
    • Eligibility criteria expanded, about 27 words
    • Study title revised
    • Study description expanded, about 1 word
  40. Site contacts updated at 1 of 192 sitesv219
  41. Site contacts updated at 1 of 192 sitesv218
  42. Site contacts updated at 1 of 192 sitesv217
  43. Study sites revised (192)v216
  • 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 is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
Trial Details
NCT Number NCT00379340
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor
Related terms Wilms Tumor
Enrollment 395 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov