NCT00945009 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 201
- group Id
- BG001
- value
- 39
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 249
- units
- Participants
- groups
- 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
- BG000
- title
- Arm 1 (Bilateral Wilms Tumors)
- 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
- BG001
- title
- Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
- 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
- BG002
- title
- Arm 3 (DHPLN)
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 22.22
- value
- 32.03
- group Id
- BG001
- spread
- 22.12
- value
- 34.70
- group Id
- BG002
- spread
- 8.70
- value
- 13.26
- group Id
- BG003
- spread
- 22.12
- value
- 31.78
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- Months
- classes
- categories
- measurements
- group Id
- BG000
- value
- 119
- group Id
- BG001
- value
- 23
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 147
- title
- Female
- measurements
- group Id
- BG000
- value
- 82
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 102
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 30
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 168
- group Id
- BG001
- value
- 35
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 211
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 8
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 4
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 31
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 37
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 142
- group Id
- BG001
- value
- 29
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 178
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 25
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 29
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 201
- group Id
- BG001
- value
- 39
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 249
- units
- Participants
- groups
- 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
- BG000
- title
- Arm 1 (Bilateral Wilms Tumors)
- 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
- BG001
- title
- Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
- 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
- BG002
- title
- Arm 3 (DHPLN)
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 22.22
- value
- 32.03
- group Id
- BG001
- spread
- 22.12
- value
- 34.70
- group Id
- BG002
- spread
- 8.70
- value
- 13.26
- group Id
- BG003
- spread
- 22.12
- value
- 31.78
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- Months
- classes
- categories
- measurements
- group Id
- BG000
- value
- 119
- group Id
- BG001
- value
- 23
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 147
- title
- Female
- measurements
- group Id
- BG000
- value
- 82
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 102
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 30
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 168
- group Id
- BG001
- value
- 35
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 211
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 8
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 4
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 31
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 37
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 142
- group Id
- BG001
- value
- 29
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 178
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 25
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 29
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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