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NCT00002611 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-02-25

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage I-V kidney cancer of one of the following histologies: * Wilms' tumor, favorable histology * Wilms' tumor, focal or diffuse anaplastic * Clear cell sarcoma * Rhabdoid tumor * (The rhabdoid tumor stratum closed to accrual effective 07/13/2001) * Prior nephrectomy or biopsy required * Prior bilateral biopsy (preferably open) with bilateral staging and pathologic evaluation required for bilateral tumor * Must begin study therapy within 5 days after nephrectomy (unless medically contraindicated) PATIENT CHARACTERISTICS: Age: * Under 16 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics
healthy Volunteers
false
maximum Age
15 Years
minimum Age
0 Years
sex
ALL
std Ages
  1. CHILD
Treatment arms and interventions
arm Groups
  1. description
    Stage I favorable histology (FH) Wilms' tumor, under 24 months of age, and tumor weight less than 550 g: After conventional surgery (nephrectomy), patients receive regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate (VCR) IV weekly on weeks 1-10, 12, 15, and 18.
    intervention Names
    1. Biological: dactinomycin
    2. Drug: vincristine sulfate
    3. Procedure: conventional surgery
    label
    Stratum 1
    type
    ACTIVE_COMPARATOR
  2. description
    Stage I FH Wilms' tumor and age 24 months and over or tumor weight at least 550 g; stage I focal anaplastic (FA) or diffuse anaplastic (DA) Wilms' tumor: Patients receive regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate (VCR) IV weekly on weeks 1-10, 12, 15, and 18.
    intervention Names
    1. Biological: dactinomycin
    2. Drug: vincristine sulfate
    label
    Stratum 2
    type
    ACTIVE_COMPARATOR
  3. description
    Stage II FH Wilms' tumor: Patients receive regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate (VCR) IV weekly on weeks 1-10, 12, 15, and 18.
    intervention Names
    1. Biological: dactinomycin
    2. Drug: vincristine sulfate
    label
    Stratum 3
    type
    ACTIVE_COMPARATOR
  4. description
    Stage III FH Wilms' tumor; stage II or III FA Wilms' tumor: After conventional surgery (nephrectomy), patients receive regimen DD-4A comprising dactinomycin DACT IV weekly on weeks 0, 6, 12, 18, and 24; doxorubicin hydrochloride IV weekly on weeks 3, 9, 15, and 21; and vincristine sulfate VCR IV weekly on weeks 1-10, 12, 15, 18, 21, and 24. Patients also undergo abdominal radiation therapy.
    intervention Names
    1. Biological: dactinomycin
    2. Drug: doxorubicin hydrochloride
    3. Drug: vincristine sulfate
    4. Procedure: conventional surgery
    5. Radiation: radiation therapy
    label
    Stratum 4
    type
    ACTIVE_COMPARATOR
  5. description
    Stage IV FH or FA Wilms' tumor: patients receive regimen DD-4A comprising dactinomycin DACT IV weekly on weeks 0, 6, 12, 18, and 24; doxorubicin hydrochloride IV weekly on weeks 3, 9, 15, and 21; and vincristine sulfate VCR IV weekly on weeks 1-10, 12, 15, 18, 21, and 24. Patients also undergo abdominal radiation therapy, and whole lung radiation therapy (at the discretion of the investigator).
    intervention Names
    1. Biological: dactinomycin
    2. Drug: doxorubicin hydrochloride
    3. Drug: vincristine sulfate
    label
    Stratum 5
    type
    ACTIVE_COMPARATOR
  6. description
    Stage V FH, FA, or DA Wilms' tumor: After bilateral conventional surgery (biopsy), patients with FH receive chemotherapy as in stratum 1 (dactinomycin IV weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate IV weeks 1-10, 12, 15, and 18) or 4 (dactinomycin IV weeks 0, 6, 12, 18, and 24; doxorubicin hydrochloride IV weeks 3, 9, 15, and 21; and vincristine sulfate VCR IV weeks 1-10, 12, 15, 18, 21, and 24). Patients with FA or DA receive chemotherapy as in stratum 7 (vincristine sulfate VCR IV weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide sulfate (CTX) IV over 1 hour on days 1-3 of weeks 6, 12, 18, and 24 and on days 1-5 of weeks 3, 9, 15, and 21; doxorubicin hydrochloride IV (beginning after CTX infusion) weeks 0, 6, 12, 18, and 24; and etoposide (VP-16) IV over 1 hour (beginning after CTX infusion) on days 1-5 of weeks 3, 9, 15, and 21. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of chemotherapy.
    intervention Names
    1. Biological: dactinomycin
    2. Biological: filgrastim
    3. Drug: cyclophosphamide
    4. Drug: doxorubicin hydrochloride
    5. Drug: etoposide
    6. Drug: vincristine sulfate
    7. Procedure: conventional surgery
    label
    Stratum 6
    type
    ACTIVE_COMPARATOR
  7. description
    Stages I-IV clear cell sarcoma): After conventional surgery (nephrectomy), patients receive vincristine sulfate VCR IV weekly on weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide sulfate (CTX) IV over 1 hour on days 1-3 of weeks 6, 12, 18, and 24 and on days 1-5 of weeks 3, 9, 15, and 21; doxorubicin hydrochloride IV (beginning after CTX infusion) weekly on weeks 0, 6, 12, 18, and 24; and etoposide (VP-16) IV over 1 hour (beginning after CTX infusion) on days 1-5 of weeks 3, 9, 15, and 21. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Patients also undergo abdominal radiotherapy and whole lung radiotherapy (if pulmonary metastases are present).
    intervention Names
    1. Biological: filgrastim
    2. Drug: doxorubicin hydrochloride
    3. Drug: etoposide
    4. Procedure: conventional surgery
    5. Radiation: radiation therapy
    label
    Stratum 7
    type
    ACTIVE_COMPARATOR
  8. description
    Stages II-IV DA Wilms' tumor: After conventional surgery (nephrectomy), Patients receive treatment as in stratum 7 (patients receive vincristine sulfate VCR IV weekly on weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide sulfate (CTX) IV over 1 hour on days 1-3 of weeks 6, 12, 18, and 24 and on days 1-5 of weeks 3, 9, 15, and 21; doxorubicin hydrochloride IV (beginning after CTX infusion) weekly on weeks 0, 6, 12, 18, and 24; and etoposide (VP-16) IV over 1 hour (beginning after CTX infusion) on days 1-5 of weeks 3, 9, 15, and 21. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Patients also undergo abdominal radiotherapy and whole lung radiotherapy (if pulmonary metastases are present).
    intervention Names
    1. Biological: filgrastim
    2. Drug: cyclophosphamide
    3. Drug: doxorubicin hydrochloride
    4. Drug: etoposide
    5. Drug: vincristine sulfate
    6. Procedure: conventional surgery
    7. Radiation: radiation therapy
    label
    Stratum 8
    type
    ACTIVE_COMPARATOR
  9. description
    Stages I-IV rhabdoid tumor: After conventional surgery (nephrectomy), patients receive carboplatin IV on days 1-2 and VP-16 IV over 1 hour (beginning after carboplatin infusion) on days 1-3 of weeks 0, 3, 9, 12, 18, and 21 and CTX IV over 1 hour on days 1-5 of weeks 6, 15, and 24. Filgrastim G-CSF is administered as on stratum 7. Patients also undergo radiation therapy. After completion of chemotherapy, patients undergo second-look conventional surgery (laparotomy) and conventional surgery (partial nephrectomy or wedge excision if feasible). After conventional surgery (second-look surgery), patients without persistent or residual disease resume chemotherapy.
    intervention Names
    1. Biological: filgrastim
    2. Drug: etoposide
    3. Procedure: conventional surgery
    4. Radiation: radiation therapy
    label
    Stratum 9
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Stratum 1
    2. Stratum 2
    3. Stratum 3
    4. Stratum 4
    5. Stratum 5
    6. Stratum 6
    name
    dactinomycin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Stratum 6
    2. Stratum 7
    3. Stratum 8
    4. Stratum 9
    name
    filgrastim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Stratum 6
    2. Stratum 8
    name
    cyclophosphamide
    type
    DRUG
  4. arm Group Labels
    1. Stratum 4
    2. Stratum 5
    3. Stratum 6
    4. Stratum 7
    5. Stratum 8
    description
    Source and Pharmacology: An anthracycline antibiotic isolated from cultures of Streptomyces peucetius. Binds to DNA and inhibits nucleic acid synthesis, with its major lethal effect occurring during the S phase of the cell cycle. Has some topoisomerase II inhibitory activity. Since it is primarily excreted by the liver, any liver impairment may enhance toxicity. 40% to 50% is excreted in the bile; \<5% in the urine. The drug has a very short initial t½ of \<20 minutes and a terminal t½ of 17 hours. Animal studies indicate cytotoxic levels persist in tissue for as long as 24 hours.
    name
    doxorubicin hydrochloride
    other Names
    1. NSC #123127
    2. (Adriamycin)
    type
    DRUG
  5. arm Group Labels
    1. Stratum 6
    2. Stratum 7
    3. Stratum 8
    4. Stratum 9
    name
    etoposide
    type
    DRUG
  6. arm Group Labels
    1. Stratum 1
    2. Stratum 2
    3. Stratum 3
    4. Stratum 4
    5. Stratum 5
    6. Stratum 6
    7. Stratum 8
    name
    vincristine sulfate
    type
    DRUG
  7. arm Group Labels
    1. Stratum 1
    2. Stratum 4
    3. Stratum 6
    4. Stratum 7
    5. Stratum 8
    6. Stratum 9
    name
    conventional surgery
    type
    PROCEDURE
  8. arm Group Labels
    1. Stratum 4
    2. Stratum 7
    3. Stratum 8
    4. Stratum 9
    name
    radiation therapy
    type
    RADIATION
Study design
primary Purpose
TREATMENT
Enrollment
count
3031
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression free survival
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.
detailed Description
OBJECTIVES: * Increase survival rate of children with favorable histology (FH) Wilms' tumor and other childhood renal tumors. * Determine whether loss of heterozygosity for chromosome 16q or 1p in tumor tissue is associated with a poorer prognosis in children with FH Wilms' tumor. * Determine whether increased DNA content in tumor cells is associated with a poorer prognosis in children with FH Wilms' tumor. * Decrease the acute and long-term morbidity in children with Wilms' tumor by limiting initial therapy and consistently using the same regimen (protocol NWTS-5/R) for patients who relapse following initial treatment. * Improve overall and disease-free survival of patients with renal tumors of unfavorable histology, including Wilms' tumor with diffuse anaplasia and clear cell sarcoma of the kidney, using a new treatment regimen that includes etoposide (VP-16) and cyclophosphamide (CTX). * Improve overall and disease-free survival in patients with malignant rhabdoid tumor of the kidney using a new treatment regimen that includes carboplatin, VP-16, and CTX. (The rhabdoid tumor stratum closed to accrual effective 07/13/2001) * Provide data regarding loss of heterozygosity for chromosomes 11p15, 16q, and 1p, age at diagnosis, precursor lesions (perilobar, intralobar, nephroblastomatosis), bilaterality, and presence of congenital anomalies required for the completion of protocol A0026 (a case-control study of risk factors for Wilms' tumor). OUTLINE: This is a multicenter study. Patients are assigned to one of nine strata based on tumor histology, stage, tumor weight, and age. * Stratum 1 (stage I favorable histology (FH) Wilms' tumor, under 24 months of age, and tumor weight less than 550 g): After nephrectomy, patients receive regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine (VCR) IV weekly on weeks 1-10, 12, 15, and 18. * Stratum 2 (stage I FH Wilms' tumor and age 24 months and over or tumor weight at least 550 g; stage I focal anaplastic (FA) or diffuse anaplastic (DA) Wilms' tumor): Patients receive therapy as in stratum 1. * Stratum 3 (stage II FH Wilms' tumor): Patients receive therapy as in stratum 1. * Stratum 4 (stage III FH Wilms' tumor; stage II or III FA Wilms' tumor): After nephrectomy, patients receive regimen DD-4A comprising DACT IV weekly on weeks 0, 6, 12, 18, and 24; doxorubicin IV weekly on weeks 3, 9, 15, and 21; and VCR IV weekly on weeks 1-10, 12, 15, 18, 21, and 24. Patients also undergo abdominal radiotherapy. * Stratum 5 (stage IV FH or FA Wilms' tumor): Patients receive chemotherapy as in stratum 4, abdominal radiotherapy, and whole lung radiotherapy (at the discretion of the investigator). * Stratum 6 (stage V FH, FA, or DA Wilms' tumor ): After bilateral biopsy, patients with FH receive chemotherapy as in stratum 1 or 4. Patients with FA or DA receive chemotherapy as in stratum 7. * Stratum 7 (stages I-IV clear cell sarcoma): After nephrectomy, patients receive VCR IV weekly on weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide (CTX) IV over 1 hour on days 1-3 of weeks 6, 12, 18, and 24 and on days 1-5 of weeks 3, 9, 15, and 21; doxorubicin IV (beginning after CTX infusion) weekly on weeks 0, 6, 12, 18, and 24; and etoposide (VP-16) IV over 1 hour (beginning after CTX infusion) on days 1-5 of weeks 3, 9, 15, and 21. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Patients also undergo abdominal radiotherapy and whole lung radiotherapy (if pulmonary metastases are present). * Stratum 8 (stages II-IV DA Wilms' tumor): Patients receive treatment as in stratum 7. * Stratum 9 (stages I-IV rhabdoid tumor): After nephrectomy, patients receive carboplatin IV on days 1-2 and VP-16 IV over 1 hour (beginning after carboplatin infusion) on days 1-3 of weeks 0, 3, 9, 12, 18, and 21 and CTX IV over 1 hour on days 1-5 of weeks 6, 15, and 24. G-CSF is administered as in stratum 7. Patients also undergo radiotherapy. (The rhabdoid tumor stratum closed to accrual effective 07/13/2001.) After completion of chemotherapy, patients undergo second-look laparotomy and partial nephrectomy or wedge excision (if feasible). After second-look surgery, patients without persistent or residual disease resume chemotherapy. Patients are followed every 3 months for 5 years, every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 207 patients will be accrued for the treatment portion of this study. (The rhabdoid tumor stratum closed to accrual effective 07/13/2001.)
Source references
references
  1. citation
    Grundy PE, Green DM, Dirks AC, Berendt AE, Breslow NE, Anderson JR, Dome JS. Clinical significance of pulmonary nodules detected by CT and Not CXR in patients treated for favorable histology Wilms tumor on national Wilms tumor studies-4 and -5: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Oct;59(4):631-5. doi: 10.1002/pbc.24123. Epub 2012 Mar 15.
    pmid
    22422736
    type
    BACKGROUND
  2. citation
    Kieran K, Anderson JR, Dome JS, Ehrlich PF, Ritchey ML, Shamberger RC, Perlman EJ, Green DM, Davidoff AM. Lymph node involvement in Wilms tumor: results from National Wilms Tumor Studies 4 and 5. J Pediatr Surg. 2012 Apr;47(4):700-6. doi: 10.1016/j.jpedsurg.2011.08.017.
    pmid
    22498384
    type
    BACKGROUND
  3. citation
    Lange J, Peterson SM, Takashima JR, Grigoriev Y, Ritchey ML, Shamberger RC, Beckwith JB, Perlman E, Green DM, Breslow NE. Risk factors for end stage renal disease in non-WT1-syndromic Wilms tumor. J Urol. 2011 Aug;186(2):378-86. doi: 10.1016/j.juro.2011.03.110. Epub 2011 Jun 17.
    pmid
    21683387
    type
    BACKGROUND
  4. citation
    Kalapurakal JA, Green DM, Haase G, Anderson JR, Dome JS, Grundy PE. Outcomes of children with favorable histology wilms tumor and peritoneal implants treated in National Wilms Tumor Studies-4 and -5. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):554-8. doi: 10.1016/j.ijrobp.2009.04.081.
    pmid
    20457352
    type
    BACKGROUND
  5. citation
    Ehrlich PF, Ferrer FA, Ritchey ML, Anderson JR, Green DM, Grundy PE, Dome JS, Kalapurakal JA, Perlman EJ, Shamberger RC. Hepatic metastasis at diagnosis in patients with Wilms tumor is not an independent adverse prognostic factor for stage IV Wilms tumor: a report from the Children's Oncology Group/National Wilms Tumor Study Group. Ann Surg. 2009 Oct;250(4):642-8. doi: 10.1097/SLA.0b013e3181b76f20.
    pmid
    19730241
    type
    BACKGROUND
  6. citation
    Ritchey M, Daley S, Shamberger RC, Ehrlich P, Hamilton T, Haase G, Sawin R; National Wilms' Tumor Study Group. Ureteral extension in Wilms' tumor: a report from the National Wilms' Tumor Study Group (NWTSG). J Pediatr Surg. 2008 Sep;43(9):1625-9. doi: 10.1016/j.jpedsurg.2008.01.067.
    pmid
    18778996
    type
    BACKGROUND
  7. citation
    van den Heuvel-Eibrink MM, Grundy P, Graf N, Pritchard-Jones K, Bergeron C, Patte C, van Tinteren H, Rey A, Langford C, Anderson JR, de Kraker J. Characteristics and survival of 750 children diagnosed with a renal tumor in the first seven months of life: A collaborative study by the SIOP/GPOH/SFOP, NWTSG, and UKCCSG Wilms tumor study groups. Pediatr Blood Cancer. 2008 Jun;50(6):1130-4. doi: 10.1002/pbc.21389.
    pmid
    18095319
    type
    BACKGROUND
  8. citation
    Breslow NE, Beckwith JB, Perlman EJ, Reeve AE. Age distributions, birth weights, nephrogenic rests, and heterogeneity in the pathogenesis of Wilms tumor. Pediatr Blood Cancer. 2006 Sep;47(3):260-7. doi: 10.1002/pbc.20891.
    pmid
    16700047
    type
    BACKGROUND
  9. citation
    Kalapurakal JA, Nan B, Norkool P, Coppes M, Perlman E, Beckwith B, Ritchey M, Breslow N, Grundy P, D'angio GJ, Green DM, Thomas PR. Treatment outcomes in adults with favorable histologic type Wilms tumor-an update from the National Wilms Tumor Study Group. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1379-84. doi: 10.1016/j.ijrobp.2004.05.057.
    pmid
    15590168
    type
    BACKGROUND
  10. citation
    Gadd S, Huff V, Huang CC, Ruteshouser EC, Dome JS, Grundy PE, Breslow N, Jennings L, Green DM, Beckwith JB, Perlman EJ. Clinically relevant subsets identified by gene expression patterns support a revised ontogenic model of Wilms tumor: a Children's Oncology Group Study. Neoplasia. 2012 Aug;14(8):742-56. doi: 10.1593/neo.12714.
    pmid
    22952427
    type
    RESULT
  11. citation
    Perlman EJ, Grundy PE, Anderson JR, Jennings LJ, Green DM, Dome JS, Shamberger RC, Ruteshouser EC, Huff V. WT1 mutation and 11P15 loss of heterozygosity predict relapse in very low-risk wilms tumors treated with surgery alone: a children's oncology group study. J Clin Oncol. 2011 Feb 20;29(6):698-703. doi: 10.1200/JCO.2010.31.5192. Epub 2010 Dec 28.
    pmid
    21189373
    type
    RESULT
  12. citation
    Fernandez CV, Anderson J, Breslow NE, Dome JS, Grundy PE, Perlman EJ, Green DM; National Wilms Tumor Study Group/Children's Oncology Group. Anthropomorphic measurements and event-free survival in patients with favorable histology Wilms tumor: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2009 Feb;52(2):254-8. doi: 10.1002/pbc.21809.
    pmid
    18989885
    type
    RESULT
see Also Links
  1. label
    Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Source notices and limitations
    Discovery and provenance
    1. release id
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      occurrences
      1. context exact
        in approximately 30% of tumors. <p id="_sm_CDR0000777841_49" tabindex="-1">In an analysis of FH Wilms tumor from 1,114 patients from <a href="/clinicaltrials/NCT00002611">NWTS-5 (COG-Q9401/NCT00002611)</a>, 28% of the tumors displayed 1q gain.[<a href="#cit/section_2.107">107</a>] </p><div class="pdq-content-list"><ul id="_sm
        end
        77480
        exact text
        NCT00002611
        start
        77469
      2. context exact
        . <p id="_sm_CDR0000777841_49" tabindex="-1">In an analysis of FH Wilms tumor from 1,114 patients from <a href="/clinicaltrials/NCT00002611">NWTS-5 (COG-Q9401/NCT00002611)</a>, 28% of the tumors displayed 1q gain.[<a href="#cit/section_2.107">107</a>] </p><div class="pdq-content-list"><ul id="_sm_CDR0000777841_64"><li>The 8-ye
        end
        77511
        exact text
        NCT00002611
        start
        77500
      3. context exact
        index="-1">Anaplastic histology can be difficult to detect in any biopsy sample because of tumor heterogeneity. Data from NWTS-4 and <a href="/clinicaltrials/NCT00002611">NWTS-5 (COG-Q9401/NCT00002611)</a> demonstrated that, because of the histological heterogeneity of Wilms tumor, a significant number of patients have anaplast
        end
        140779
        exact text
        NCT00002611
        start
        140768
      4. context exact
        y can be difficult to detect in any biopsy sample because of tumor heterogeneity. Data from NWTS-4 and <a href="/clinicaltrials/NCT00002611">NWTS-5 (COG-Q9401/NCT00002611)</a> demonstrated that, because of the histological heterogeneity of Wilms tumor, a significant number of patients have anaplastic histology that is missed dur
        end
        140810
        exact text
        NCT00002611
        start
        140799
      5. context exact
        tudies. </p> <p id="_1021" tabindex="-1">The major treatment and study conclusions of NWTS-1, NWTS-2, NWTS-3, NWTS-4, and <a href="/clinicaltrials/NCT00002611">NWTS-5</a> are as follows: </p> <div class="pdq-content-list"><ol id="_116"><li>Routine, postoperative radiation therapy of the flank is not neces
        end
        175266
        exact text
        NCT00002611
        start
        175255
      6. context exact
        ar EFS rate of 87.3%, compared with the 4-year EFS rate of 68.8% (<em>P</em> = .042) for stage I and stage II patients treated on the <a href="/clinicaltrials/NCT00002611">NWTS-5</a> trial. Patients with stage III and stage IV disease had a 4-year EFS rate of 90.2% when treated with regimen M (see <a href="/types/kidney/hp/wil
        end
        193426
        exact text
        NCT00002611
        start
        193415
      7. context exact
        " tabindex="-1">In the <a href="/clinicaltrials/NCT00352534">AREN0532 (NCT00352534)</a> trial, the COG validated the findings from the <a href="/clinicaltrials/NCT00002611">NWTS-5</a> trial that nephrectomy only is appropriate therapy for patients younger than 2 years at diagnosis with stage I FH Wilms tumor that weighed less th
        end
        211727
        exact text
        NCT00002611
        start
        211716
      8. context exact
        EFS and OS rate estimates were 100% in AREN0321, compared with 70% and 81.5%, respectively, in an updated analysis of 27 patients from <a href="/clinicaltrials/NCT00002611">NWTS-5</a> (median follow-up, 13.3 years). One patient with diffuse anaplasia relapsed 4.12 years after diagnosis on the AREN0321 trial.</li><li>The addition
        end
        215233
        exact text
        NCT00002611
        start
        215222
      9. context exact
        ed statistical significance.[<a href="#cit/section_2.217">217</a>]</p> <p id="_980" tabindex="-1">On the NWTS-3, NWTS-4, and <a href="/clinicaltrials/NCT00002611">NWTS-5</a> trials, patients with intraoperative spill were divided into two groups: (1) those with diffuse spillage involving the whole abdominal cavity; and
        end
        220777
        exact text
        NCT00002611
        start
        220766
      10. context exact
        st CT scan only):</p> <div class="pdq-content-list"><ol id="_990"><li>A retrospective review of 186 patients from NWTS-4 and <a href="/clinicaltrials/NCT00002611">NWTS-5</a> with CT-only&#8211;detected lung nodules reported on the use of doxorubicin, vincristine, and dactinomycin versus the use of two drugs.[<a href=
        end
        242683
        exact text
        NCT00002611
        start
        242672
      11. context exact
        ng these children.[<a href="#cit/section_2.288">288</a>] </p> <p id="_807" tabindex="-1">Historically, based on the NWTS-4 and <a href="/clinicaltrials/NCT00002611">NWTS-5</a> trials and trials performed in Europe, patients with bilateral Wilms tumor have had a lower EFS and OS than have patients with localized Wilms tumo
        end
        261868
        exact text
        NCT00002611
        start
        261857
      12. context exact
        n therapy, and chemotherapy):</p> <div class="pdq-content-list"><ol id="_868"><li>Fifty-eight patients were treated on the <a href="/clinicaltrials/NCT00002611">NWTS-5</a> relapse protocol with surgical excision when feasible, radiation therapy, and courses of vincristine, doxorubicin, and cyclophosphamide alternating
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        Updated: April 15, 2025
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        April 15, 2025
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        in approximately 30% of tumors. <p id="_sm_CDR0000777841_49" tabindex="-1">In an analysis of FH Wilms tumor from 1,114 patients from <a href="/clinicaltrials/NCT00002611">NWTS-5 (COG-Q9401/NCT00002611)</a>, 28% of the tumors displayed 1q gain.[<a href="#cit/section_11.53">53</a>] </p><div class="pdq-content-list"><ul id="_sm_
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        . <p id="_sm_CDR0000777841_49" tabindex="-1">In an analysis of FH Wilms tumor from 1,114 patients from <a href="/clinicaltrials/NCT00002611">NWTS-5 (COG-Q9401/NCT00002611)</a>, 28% of the tumors displayed 1q gain.[<a href="#cit/section_11.53">53</a>] </p><div class="pdq-content-list"><ul id="_sm_CDR0000777841_64"><li>The 8-yea
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        April 30, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice