NCT00304070 · STUDY IN CONTEXT

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical 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

The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.

Source null

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secondary · POSTED

The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy

Source null

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secondary · POSTED

Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication.

Sixty-nine eligible patients received surgery of the primary tumor site or RPLND. Complication rates were considered over the entire population regardless of Arm/Group assignment. One patient had grade 3 abdominal pain attributed to surgery.

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secondary · POSTED

The number eligible patients who have lymph node involvement by imaging at study enrollment.

Seventy-five eligible patients had tumor imaging done at the time of study enrollment and evaluated for the presence of lymph node involvement

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secondary · POSTED

The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group.

The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group (Number of patients from Brazil: 23. Number of patients not from Brazil: 31)

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secondary · POSTED

The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.

Fifty-eight eligible patients had material examined for the presence of (beta)-catenin mutations.

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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-adrenocortical-carcinoma
nct id: NCT00304070
trial label: Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical 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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0000
source section id
NCT00304070-om-0000
source outcome index
0
endpoint
Five Year Event-free Survival (EFS)
endpoint definition
The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.
time origin
Up to five years after enrollment
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-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0001
source section id
NCT00304070-om-0001
source outcome index
1
endpoint
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
endpoint definition
The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy
time origin
Up to 182 Days After Enrollment
analysis role
secondary
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-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0002
source section id
NCT00304070-om-0002
source outcome index
2
endpoint
Complications Associated With Radical Adrenalectomy and RLND
endpoint definition
Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication.
time origin
Up to 1 month after surgery
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Sixty-nine eligible patients received surgery of the primary tumor site or RPLND. Complication rates were considered over the entire population regardless of Arm/Group assignment. One patient had grade 3 abdominal pain attributed to surgery.
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-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0003
source section id
NCT00304070-om-0003
source outcome index
3
endpoint
Frequency of Lymph Node Involvement by Imaging.
endpoint definition
The number eligible patients who have lymph node involvement by imaging at study enrollment.
time origin
At study enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Seventy-five eligible patients had tumor imaging done at the time of study enrollment and evaluated for the presence of lymph node involvement
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-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0004
source section id
NCT00304070-om-0004
source outcome index
4
endpoint
Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.
endpoint definition
The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group.
time origin
At study enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group (Number of patients from Brazil: 23. Number of patients not from Brazil: 31)
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-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0005
source section id
NCT00304070-om-0005
source outcome index
5
endpoint
Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.
endpoint definition
The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.
time origin
Patients who had surgery at time of enrollment.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Fifty-eight eligible patients had material examined for the presence of (beta)-catenin mutations.
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-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0000
arm key
OG000
arm label
Stratum 1
regimen
Stage I Disease (surgery, observation)
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0000
arm key
OG001
arm label
Stratum 2
regimen
Stage II Disease (surgery, observation)
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0000
arm key
OG002
arm label
Stratum 3
regimen
Stage III OR IV Disease (chemotherapy)
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0001
arm key
OG000
arm label
Stratum 3
regimen
Stage III OR IV Disease (chemotherapy)
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0002
arm key
OG000
arm label
All Patients
regimen
The complication rate is estimated as the proportion of evaluable patients that have a complication as it relates to surgery.
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0003
arm key
OG000
arm label
All Patients
regimen
Regardless of Arm/Group assignment, the frequency reflects the total number of patients who had lymph node involvement by imaging at study enrollment.
analyzed count
75
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0004
arm key
OG000
arm label
All Patients
regimen
Regardless of Arm/Group assignment, the number of eligible patients from whom blood was obtained as well as the frequency of the relevant mutation in each group.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
outcome key
om-0005
arm key
OG000
arm label
All Patients
regimen
Regardless of Arm/Group assignment, the number of eligible patients who had surgery at study enrollment and have A43 del33bp mutation of (beta)-catenins.
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00304070-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00304070
harm key
EG000
source section id
NCT00304070-ae
event group key
EG000
event group label
Stratum 3
serious affected
1
serious at risk
39
other affected
38
other at risk
39
frequency threshold
0
collection period
Source null
event definition
Serious and other adverse events were collected only for Stratum 3 patients who received systemic intervention. Stratum 1 and Stratum 2 patients did not receive chemotherapy as part of protocol treatment.
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