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← Malignant Kidney Neoplasm

NCT00945009 · STUDY IN CONTEXT

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Probability of no relapse, secondary malignancy, or death whichever occurs first

All eligible BWT patients. 6 patients were excluded due to ineligibility and 6 patients were excluded due to protocol violation.

→

primary · POSTED

Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT).

Eligible and evaluable Bilateral Wilms Tumor patients who completed pre-nephrectomy chemotherapy (VAD). 49 patients who did not complete VAD were excluded.

→

primary · POSTED

To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.

Eligible and evaluable patients with diffuse hyperplastic perilobar nephroblastomatosis (DPHLN).

→

primary · POSTED

Percentage of patients who experienced partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.

Eligible and evaluable patients with unilateral high risk tumors who had partial or complete nephrectomy. 16 total patients were excluded (1 ineligible, 1 inevaluable, 1 violated protocol, and 13 did not have definitive surgery (partial or complete nephrectomy).

→

primary · POSTED

Percentage of Bilateral Wilms Tumor (BWT) patients who undergo definitive surgery by week 12 after initiation of chemotherapy.

Eligible and evaluable Bilateral Wilms Tumor patients. 6 patients were excluded due to ineligible and 6 patients were excluded due to protocol violation.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-kidney-neoplasm
nct id
NCT00945009
trial label
Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
5
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0000
    source section id
    NCT00945009-om-0000
    source outcome index
    0
    endpoint
    Event-Free Survival (EFS)
    endpoint definition
    Probability of no relapse, secondary malignancy, or death whichever occurs first
    time origin
    4 years from study enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible BWT patients. 6 patients were excluded due to ineligibility and 6 patients were excluded due to protocol violation.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0001
    source section id
    NCT00945009-om-0001
    source outcome index
    1
    endpoint
    Kidney Preservation After Preoperative Chemotherapy
    endpoint definition
    Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT).
    time origin
    12 weeks from study entry
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable Bilateral Wilms Tumor patients who completed pre-nephrectomy chemotherapy (VAD). 49 patients who did not complete VAD were excluded.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0002
    source section id
    NCT00945009-om-0002
    source outcome index
    2
    endpoint
    Number of Patients Without Complete Removal of at Least One Kidney
    endpoint definition
    To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.
    time origin
    12 weeks from the study entry
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable patients with diffuse hyperplastic perilobar nephroblastomatosis (DPHLN).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0003
    source section id
    NCT00945009-om-0003
    source outcome index
    3
    endpoint
    Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy
    endpoint definition
    Percentage of patients who experienced partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.
    time origin
    12 weeks from study entry
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable patients with unilateral high risk tumors who had partial or complete nephrectomy. 16 total patients were excluded (1 ineligible, 1 inevaluable, 1 violated protocol, and 13 did not have definitive surgery (partial or complete nephrectomy).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0004
    source section id
    NCT00945009-om-0004
    source outcome index
    4
    endpoint
    Percentage of Patients Who Had Definitive Surgical Treatment
    endpoint definition
    Percentage of Bilateral Wilms Tumor (BWT) patients who undergo definitive surgery by week 12 after initiation of chemotherapy.
    time origin
    12 weeks from study entry
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable Bilateral Wilms Tumor patients. 6 patients were excluded due to ineligible and 6 patients were excluded due to protocol violation.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm 1 (Bilateral Wilms Tumors)
    regimen
    Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00945009-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm 1 (Bilateral Wilms Tumors)
    regimen
    Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
    analyzed count
    140
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00945009-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm 3 (DHPLN)
    regimen
    Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00945009-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
    regimen
    Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00945009-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm 1 (Bilateral Wilms Tumors)
    regimen
    Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00945009-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    harm key
    EG000
    source section id
    NCT00945009-ae
    event group key
    EG000
    event group label
    Arm 1 (Bilateral Wilms Tumors)
    serious affected
    12
    serious at risk
    189
    other affected
    34
    other at risk
    189
    frequency threshold
    0
    collection period
    From enrollment to up to 10 years of follow-up
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    harm key
    EG001
    source section id
    NCT00945009-ae
    event group key
    EG001
    event group label
    Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
    serious affected
    1
    serious at risk
    36
    other affected
    1
    other at risk
    36
    frequency threshold
    0
    collection period
    From enrollment to up to 10 years of follow-up
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-kidney-neoplasm
    nct id
    NCT00945009
    harm key
    EG002
    source section id
    NCT00945009-ae
    event group key
    EG002
    event group label
    Arm 3 (DHPLN)
    serious affected
    0
    serious at risk
    9
    other affected
    0
    other at risk
    9
    frequency threshold
    0
    collection period
    From enrollment to up to 10 years of follow-up
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice