NCT00945009 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- 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
- FG000
- 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
- FG001
- 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
- FG002
- title
- Arm 3 (DHPLN)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 21
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 3
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Protocol Violation
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Inevaluable
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Refusal of further protocol
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 201
- group Id
- FG001
- num Subjects
- 39
- group Id
- FG002
- num Subjects
- 9
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 156
- group Id
- FG001
- num Subjects
- 32
- group Id
- FG002
- num Subjects
- 6
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 45
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 3
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- 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
- FG000
- 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
- FG001
- 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
- FG002
- title
- Arm 3 (DHPLN)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 21
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 3
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Protocol Violation
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Inevaluable
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Refusal of further protocol
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 201
- group Id
- FG001
- num Subjects
- 39
- group Id
- FG002
- num Subjects
- 9
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 156
- group Id
- FG001
- num Subjects
- 32
- group Id
- FG002
- num Subjects
- 6
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 45
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 3
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle