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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
View on ClinicalTrials.gov ↗

Amendment history

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

  1. Minor

    Study sites revised (227)

    Show what changed: Study sites
    SaintOSF JudeChildren's MidwestHospital Affiliateof Illinois

    Study Status, Arms and Interventions, Contacts/Locationsv265

  2. Minor

    Trial completed

    Completion moved earlier from Nov 18, 2026 to Mar 31, 2026; Study sites revised (227)

    Show what changed: Study sites
    Cedars-Sinai Medical Center

    Study Status, Contacts/Locationsv264

  3. Notable

    Start date: Feb 26, 2007 to Apr 30, 2007

    Completion date: Mar 31, 2026 to Nov 18, 2026; Eligibility criteria expanded, about 109 words; Study description expanded, about 34 words; and 1 more

    Show all 5 changes in this update
    • Notable Start date: Feb 26, 2007 to Apr 30, 2007
    • Minor Completion date: Mar 31, 2026 to Nov 18, 2026
    • Minor Eligibility criteria expanded, about 109 words
      Show what changed
      Inclusion Criteria: Patients must be less than 30 years of age at the time of diagnosis Prior to enrollment on AREN0533, all patients must have been enrolled on AREN03B2 for central pathology review. Stage III patients with LOH transferring from AREN0532 may be enrolled on this study. Eligible patients for AREN0533 mus [...] Newly diagnosed Wilms' tumor meeting 1 of the following criteria: Stage IV disease with favorable histology Wilms tumor with or without loss of heterozygosity (LOH) for 1p and 16q or Newly diagnosed Stage III disease with favorable histology Wilms tumor with LOH for 1p and 16q tr [...] [...]
    • Minor Study description expanded, about 34 words
      Show what changed
      PRIMARY OBJECTIVES: I. DetermineTo demonstrate that patients with Stage IV favorable histology (FH) Wilms tumor with pulmonary metastases only, who have complete resolution of the pulmonary lesions after 6 weeks of DD-4A chemotherapy (vincristine, dactinomycin, and doxorubicin), called Rapid Complete Responders (RCR), will have at least an 85% 4- year event-free survival (EFS) ofafter patientstherapy with stageadditional IVDD-4A favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete resolution of pulmonary lesionsand without whole lung irradiation treated with D [...] [...]
    • Minor Study sites revised (227)
      Show what changed
      University of FloridaUF Health ScienceCancer CenterInstitute - Gainesville Michigan State University VCU ClinicalMassey Center Virginia Commonwealth University/MasseyComprehensive Cancer Center

    Study Identification, Study Status, Oversight, Study Description, Eligibility, Contacts/Locationsv263

  4. Minor

    Completion date: Sep 30, 2025 to Mar 31, 2026

    Study Statusv262

  5. Minor

    Completion date: Sep 30, 2025

    Study sites revised (227)

    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 Corewell Health Grand Rapids Hospitals - Butterworth Hospital Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital at Spectrum Health SpectrumCorewell Health atChildren's Corewell ButterworthHealth CampusWilliam Beaumont University Hospital BeaumontUniversity of Missouri Children's Hospital-Royal Oak William Beaumont Hospital-Royal Oak Columbia Regional NYU WinthropLangone Hospital - Long Island University of Wisconsin Carbone [...] [...]

    Study Status, Arms and Interventions, Contacts/Locationsv261

Show 45 earlier versions

  1. Minor

    Study sites revised (227)

    Show what changed: Study sites
    Tulane University School of Medicine MU Health Sciences- University Hospital/Ellis Fischel Cancer Center UniversityCHU ofde Missouri Quebec- Ellis Fischel Centre Hospitalier Universitaire de Quebecl'Universite Laval (CHUL)

    Study Status, Arms and Interventions, Contacts/Locationsv260

  2. Minor

    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

    Show what changed: Study description
    [...] disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis under [...] gosity (LOH) who are rapid complete responders (RCR) (i.e., all pulmonary metastases disappear) proceed to regimen DD4A (wee [...] ulmonary metastases in combination with pulmonary metastases) proceed to regimen M (weeks 7-31). Patients with initially [...] s 8, 9, 11, 12, 13, 16, 22, 28, and 31; and dactinomycin IV orand doxorubicin hydrochloride IV over 15 minutes once in weeks [...] nts who begin study treatment after undergoing resection of all pulmonary metastases are not eligible for [...] [...]

    Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Contacts/Locationsv259

  3. Minor

    2 amendments

    2 re-verifications since 2021-03-23, no change to tracked fields

    v257-v258

  4. Notable

    Primary completion date: Oct 2015 to Jun 30, 2016

    Trial status: Completed to Active, Not Recruiting; Start date: Feb 2007 to Feb 26, 2007

    Study Statusv256

  5. Minor

    Study Status, References

    Re-verified, no change to tracked fields

    v255

  6. Notable

    Results first posted: Jun 14, 2017

    Primary endpoints revised (3); Trial status: Active, Not Recruiting to Completed; Secondary endpoint revised

    Show what changed: Primary endpoints
    EFSEvent ofFree patients with stage IV and rapid complete responseSurvival (RCREFS) ofProbability Event lungFree metastasesSurvival Probability EFSEvent ofFree patientsSurvival with stage IV and slow incomplete response (SIR) of lung metastases EFS of patients with stage IV, non lung disease only, and stage III with LOH 1p and 16qProbability
    Show what changed: Secondary endpoints
    CorrelateEvent betweenFree Survival Associated With the burdenBurden of pulmonaryPulmonary metastaticMetastatic disease with outcome in patients with stage IV FH Wilms' tumorDisease

    Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv254

  7. Minor

    Study arms: 1 to 5

    Study Status, Study Design, Arms and Interventionsv253

  8. Minor

    Primary completion date changed from estimate of Jul 2016 to Oct 2015

    Study Statusv252

  9. Minor

    2 amendments

    2 re-verifications since 2014-10-09, no change to tracked fields

    v250-v251

  10. Notable

    Primary endpoints revised (3)

    Study description expanded, about 25 words

    Show what changed: Primary endpoints
    EFS of patients with stage IV and rapidlyrapid completelycomplete respondingresponse (RCR) of lung metastases EFS of patients with stage IV, non lung disease only, and stage III/IV with LOH 1p and 16q
    Show what changed: Study description
    [...] disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis under [...] gosity (LOH) who are rapid complete responders (RCR) (i.e., all pulmonary metastases disappear) proceed to regimen DD4A (wee [...] ulmonary metastases in combination with pulmonary metastases) proceed to regimen M (weeks 7-31). Patients with initially [...] s 8, 9, 11, 12, 13, 16, 22, 28, and 31; and dactinomycin IV andor doxorubicin hydrochloride IV over 15 minutes once in weeks [...] nts who begin study treatment after undergoing resection of all pulmonary metastases are not eligible for [...] [...]

    Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measuresv249

  11. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v248

  12. Notable

    Primary endpoints: 1 to 3

    Trial status: Recruiting to Active, Not Recruiting; Enrollment target: estimated 400 to confirmed 395; Study sites: 201 to 207; and 6 more

    Show all 10 changes in this update
    • Notable Primary endpoints: 1 to 3
      Show what changed
      Event-freeEFS survivalof aspatients measuredwith bystage WoolsonIV and anrapidly O'Brien-Flemingcompletely Boundaryresponding at(RCR) 4lung yearsmetastases EFS of patients with stage IV and slow incomplete response (SIR) of lung metastases EFS of patients with stage IV, non lung disease only and stage III/IV
    • Minor Trial status: Recruiting to Active, Not Recruiting
    • Minor Enrollment target: estimated 400 to confirmed 395
    • Minor Study sites: 201 to 207
    • Minor 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…
    • Minor Eligibility criteria shortened, about 35 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: Newly diagnosed Wilms' tumor meeting 1 of the following criteria: Stage IV disease [...] ts must begin therapy within 14 days after surgery or biopsy (day 0), unless medically contraindicated Extra-pulmonary metastases include lymph node involvement in the hilum and/or mediastinum deemed by the treating institution to represent malignant disease, or positive cytology-proven pleural effusions No bilateral Wilms' tumors (stage IV) Patients should be referred to COG-AREN0534 Previously enrolled in clinical trial COG-AREN03B2 PATIENT CHARACTERISTICS: Karnofsky pe [...] [...]
    • Minor Secondary endpoints expanded, about 18 words
      Show what changed
      Correlate between the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor
    • Minor Study description shortened, about 9 words
      Show what changed
      PRIMARY OBJECTIVES: Primary I. Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete reso [...] g vincristine, dactinomycin, and doxorubicin hydrochloride. II. Determine the 4-year EFS of these patients who do not have r [...] amide and etoposide to a modified-regimen DD4A (regimen M). III. Determine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16q treated with regimen M. SecondarySECONDARY OBJECTIVES: I. Correlate the burden of pulmo [...] [...]
    • Minor Study title revised
      Show what changed
      [...] ng Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
    • Minor Study arms: 0 to 1

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv247

  13. Minor

    Study Status

    Re-verified, no change to tracked fields

    v246

  14. Minor

    Site contacts updated at 1 of 201 sites

    Study Status, Contacts/Locationsv245

  15. Minor

    Study sites: 200 to 201

    Study Status, Contacts/Locationsv244

  16. Minor

    Site contacts updated at 1 of 200 sites

    Study Status, Contacts/Locationsv243

  17. Minor

    Study sites: 199 to 200

    Study Status, Contacts/Locationsv242

  18. Minor

    Study sites revised (199)

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

    Study Status, Contacts/Locationsv241

  19. Minor

    Site contacts updated at 1 of 199 sites

    Study Status, Contacts/Locationsv240

  20. Minor

    Site contacts updated at 1 of 199 sites

    Study Status, Contacts/Locationsv239

  21. Notable

    Primary completion date: Jan 2012 to Jul 2016

    Study sites: 195 to 199

    Study Status, Contacts/Locationsv238

  22. Minor

    Site contacts updated at 1 of 195 sites

    Study Status, Contacts/Locationsv237

  23. Minor

    Study Status

    Re-verified, no change to tracked fields

    v236

  24. Minor

    Study sites: 194 to 195

    Study Status, Contacts/Locationsv235

  25. Minor

    Study sites: 193 to 194

    Study Status, Contacts/Locationsv234

  26. Minor

    Study sites revised (193)

    Show what changed: Study sites
    IndianaRiley's University Melvin and Bren SimonChildren Cancer Center at Riley Hospital for Children

    Study Status, Contacts/Locationsv233

  27. Minor

    Site details revised at 2 of 193 sites

    Study Status, Contacts/Locationsv232

  28. Minor

    Site details revised at 1 of 193 sites

    Study Status, Contacts/Locationsv231

  29. Minor

    Site details revised at 3 of 193 sites

    Study Status, Contacts/Locationsv230

  30. Minor

    Site details revised at 1 of 193 sites

    Study Status, Contacts/Locationsv229

  31. Minor

    Site details revised at 1 of 193 sites

    Study Status, Contacts/Locationsv228

  32. Minor

    Site details revised at 1 of 193 sites

    Study Status, Contacts/Locationsv227

  33. Minor

    Site contacts updated at 1 of 193 sites

    Study Status, Contacts/Locationsv226

  34. Minor

    Study Status

    Re-verified, no change to tracked fields

    v225

  35. Minor

    Study sites revised (193)

    Show what changed: Study sites
    Children's &and Women's Hospital of British Columbia

    Study Status, Contacts/Locationsv224

  36. Minor

    Study sites revised (193)

    Show what changed: Study sites
    WalterNational Reed ArmyNaval Medical Center

    Study Status, Contacts/Locationsv223

  37. Minor

    Study sites: 192 to 193

    Study Status, Contacts/Locationsv222

  38. Minor

    Study Status

    Re-verified, no change to tracked fields

    v221

  39. Minor

    Enrollment target: 295 to 400

    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 description expanded, about 1 word; and 1 more

    Show all 5 changes in this update
    • Minor Enrollment target: 295 to 400
    • Minor 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)…
    • Minor Eligibility criteria expanded, about 27 words
      Show what changed
      DISEASE CHARACTERISTICS: Newly diagnosed Wilms' tumor meeting 1 of the following criteria: Stage IV disease [...] ts must begin therapy within 14 days after surgery or biopsy (day 0), unless medically contraindicated Extra-pulmonary metastases include lymph node involvement in the hilum and/or mediastinum deemed by the treating institution to represent malignant disease, or positive cytology-proven pleural effusions No bilateral Wilms' tumors (stage IV) Patients should be referred to COG-AREN05 [...]
    • Minor Study description expanded, about 1 word
      Show what changed
      [...] FS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete reso [...] ine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16 [...] atic disease with outcome in patients with stage IV FH Wilms' tumor. OUTLINE: This is a multicenter study. Regimen DD4A ( [...] disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis under [...] ed periodically for 10 years. PROJECTED ACCRUAL: A total of 295400 patients will be accrued for this study.
    • Minor Study title revised
      Show what changed
      [...] ng Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

    Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibilityv220

  40. Minor

    Site contacts updated at 1 of 192 sites

    Study Status, Contacts/Locationsv219

  41. Minor

    Site contacts updated at 1 of 192 sites

    Study Status, Contacts/Locationsv218

  42. Minor

    Site contacts updated at 1 of 192 sites

    Study Status, Contacts/Locationsv217

  43. Minor

    Study sites revised (192)

    Show what changed: Study sites
    Children's Hospital Colorado Center for Cancer and Blood Disorders

    Study Status, Contacts/Locationsv216

  • 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 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 Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor
Enrollment 395 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov