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NCT00945009 · FLOW

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Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor · Source last updated 2026-06-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    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
    id
    FG000
    title
    Arm 1 (Bilateral Wilms Tumors)
  2. description
    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
    id
    FG001
    title
    Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
  3. description
    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. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
    id
    FG002
    title
    Arm 3 (DHPLN)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Ineligible
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Inevaluable
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Refusal of further protocol
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        201
      2. group Id
        FG001
        num Subjects
        39
      3. group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        156
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    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
    id
    FG000
    title
    Arm 1 (Bilateral Wilms Tumors)
  2. description
    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
    id
    FG001
    title
    Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
  3. description
    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. Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgical resection Vincristine Sulfate: Given IV
    id
    FG002
    title
    Arm 3 (DHPLN)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Ineligible
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Inevaluable
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Refusal of further protocol
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        201
      2. group Id
        FG001
        num Subjects
        39
      3. group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        156
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice