TriangleNCT00352534 · STUDY IN CONTEXT
Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I
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
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Probability of being alive after 4 years in the study.
Number of contralateral kidney lesions during follow-up.
Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up
Reported safety
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-wilms-tumor
- nct id
- NCT00352534
- trial label
- Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I
- 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
- 4
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0000
- source section id
- NCT00352534-om-0000
- source outcome index
- 0
- endpoint
- Event Free Survival Probability
- endpoint definition
- Probability of no relapse, secondary malignancy, or death after 4 year in the study.
- time origin
- 4 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible very low risk or standard risk patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0001
- source section id
- NCT00352534-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) Probability
- endpoint definition
- Probability of being alive after 4 years in the study.
- time origin
- 4 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible very low risk or standard risk patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0002
- source section id
- NCT00352534-om-0002
- source outcome index
- 2
- endpoint
- Incidence of Contralateral Kidney Lesions
- endpoint definition
- Number of contralateral kidney lesions during follow-up.
- time origin
- During follow-up
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Very low risk patients treated by nephrectomy and observation only.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0003
- source section id
- NCT00352534-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Renal Failure
- endpoint definition
- Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up
- time origin
- During follow-up
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Very low risk patients that have metachronous relapse.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Very Low Risk
- regimen
- Very Low Risk
- analyzed count
- 116
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Standard Risk, Stage I or II, With LOH
- regimen
- Standard Risk, Stage I or II, with LOH
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Standard Risk, Stage III
- regimen
- Standard Risk, Stage III
- analyzed count
- 535
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Very Low Risk
- regimen
- Very Low Risk
- analyzed count
- 116
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Standard Risk, Stage I or II, With LOH
- regimen
- Standard Risk, Stage I or II, with LOH
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Standard Risk, Stage III
- regimen
- Standard Risk, Stage III
- analyzed count
- 535
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Very Low Risk
- regimen
- Very Low Risk
- analyzed count
- 116
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Very Low Risk
- regimen
- Very Low Risk
- analyzed count
- 116
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352534-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- harm key
- EG000
- source section id
- NCT00352534-ae
- event group key
- EG000
- event group label
- Very Low Risk Disease
- serious affected
- 0
- serious at risk
- 116
- other affected
- 0
- other at risk
- 116
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Adverse Events were reported for eligible patients only.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- harm key
- EG001
- source section id
- NCT00352534-ae
- event group key
- EG001
- event group label
- Low Risk, Stage I or II, no LOH
- serious affected
- 0
- serious at risk
- 51
- other affected
- 2
- other at risk
- 51
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Adverse Events were reported for eligible patients only.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- harm key
- EG002
- source section id
- NCT00352534-ae
- event group key
- EG002
- event group label
- Standard Risk, Stage I or II, With LOH
- serious affected
- 0
- serious at risk
- 32
- other affected
- 0
- other at risk
- 32
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Adverse Events were reported for eligible patients only.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- harm key
- EG003
- source section id
- NCT00352534-ae
- event group key
- EG003
- event group label
- Standard Risk, Stage III
- serious affected
- 20
- serious at risk
- 535
- other affected
- 31
- other at risk
- 535
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Adverse Events were reported for eligible patients only.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-wilms-tumor
- nct id
- NCT00352534
- harm key
- EG004
- source section id
- NCT00352534-ae
- event group key
- EG004
- event group label
- High Risk
- serious affected
- 1
- serious at risk
- 40
- other affected
- 0
- other at risk
- 40
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Adverse Events were reported for eligible patients only.
- 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