NCT00379340 · STUDY IN CONTEXT

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV 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 after 4 year in the study.

Source null

→

primary · POSTED

Probability of no relapse, secondary malignancy, or death after 4 year in the study.

Analysis includes only eligible patients.

→

primary · POSTED

Probability of no relapse, secondary malignancy, or death after 4 year in the study

All eligible patients were included in this analysis.

→

secondary · POSTED

Probability of no relapse, secondary malignancy, or death after 4 year in the study.

Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.

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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-wilms-tumor
nct id: NCT00379340
trial label: Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV 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: 4
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-wilms-tumor
nct id
NCT00379340
outcome key
om-0000
source section id
NCT00379340-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
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
NCT00379340
outcome key
om-0001
source section id
NCT00379340-om-0001
source outcome index
1
endpoint
Event Free Survival (EFS) Probability
endpoint definition
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
time origin
At 4 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis includes only eligible 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
NCT00379340
outcome key
om-0002
source section id
NCT00379340-om-0002
source outcome index
2
endpoint
Event Free Survival Probability
endpoint definition
Probability of no relapse, secondary malignancy, or death after 4 year in the study
time origin
At 4 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients were included in this analysis.
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
NCT00379340
outcome key
om-0003
source section id
NCT00379340-om-0003
source outcome index
3
endpoint
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
endpoint definition
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
time origin
At 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.
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
NCT00379340
outcome key
om-0000
arm key
OG000
arm label
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
regimen
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
analyzed count
120
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00379340-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-wilms-tumor
nct id
NCT00379340
outcome key
om-0001
arm key
OG000
arm label
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
regimen
Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A doxorubicin hydrochloride: Given IV liposomal vincristine sulfate: Given IV conventional surgery 3-dimensional conformal radiation therapy dactinomycin: Given IV cyclophosphamide: Given IV etoposide: Given IV
analyzed count
135
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00379340-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-wilms-tumor
nct id
NCT00379340
outcome key
om-0002
arm key
OG000
arm label
Stage III/IV With LOH 1p and 16q Treated With Regimen M
regimen
Stage III/IV with LOH 1p and 16q treated with Regimen M doxorubicin hydrochloride: Given IV liposomal vincristine sulfate: Given IV conventional surgery 3-dimensional conformal radiation therapy dactinomycin: Given IV cyclophosphamide: Given IV etoposide: Given IV
analyzed count
52
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00379340-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-wilms-tumor
nct id
NCT00379340
outcome key
om-0002
arm key
OG001
arm label
Stage IV With Non-lung Disease Treated With Regimen M
regimen
Stage IV with non-lung disease treated with Regimen M doxorubicin hydrochloride: Given IV liposomal vincristine sulfate: Given IV conventional surgery dactinomycin: Given IV cyclophosphamide: Given IV etoposide: Given IV
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00379340-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-wilms-tumor
nct id
NCT00379340
outcome key
om-0003
arm key
OG000
arm label
Lung Mets <= 1cm
regimen
Lung mets \<= 1cm
analyzed count
147
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00379340-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-wilms-tumor
nct id
NCT00379340
outcome key
om-0003
arm key
OG001
arm label
Lung Mets > 1cm
regimen
Lung mets \> 1cm
analyzed count
150
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00379340-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-wilms-tumor
nct id
NCT00379340
harm key
EG000
source section id
NCT00379340-ae
event group key
EG000
event group label
Stage IV and Rapid Complete Response (RCR) of Lung Metastases
serious affected
3
serious at risk
120
other affected
11
other at risk
120
frequency threshold
0
collection period
Source null
event definition
Source null
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
NCT00379340
harm key
EG001
source section id
NCT00379340-ae
event group key
EG001
event group label
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
serious affected
10
serious at risk
135
other affected
90
other at risk
135
frequency threshold
0
collection period
Source null
event definition
Source null
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
NCT00379340
harm key
EG002
source section id
NCT00379340-ae
event group key
EG002
event group label
Stage III/IV With LOH 1p and 16q Treated With Regimen M
serious affected
3
serious at risk
52
other affected
35
other at risk
52
frequency threshold
0
collection period
Source null
event definition
Source null
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
NCT00379340
harm key
EG003
source section id
NCT00379340-ae
event group key
EG003
event group label
Stage IV With Non-lung Disease Treated With Regimen M
serious affected
11
serious at risk
50
other affected
37
other at risk
50
frequency threshold
0
collection period
Source null
event definition
Source null
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
NCT00379340
harm key
EG004
source section id
NCT00379340-ae
event group key
EG004
event group label
Stage IV With Lung Metastases
serious affected
0
serious at risk
23
other affected
1
other at risk
23
frequency threshold
0
collection period
Source null
event definition
Source null
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