NCT00567567 · STUDY IN CONTEXT

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

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

Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)

All eligible, randomized patients.

→

primary · POSTED

Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion (primary or metastases) with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive.

Eligible patients evaluated for response at the end of induction therapy.

→

primary · POSTED

Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.

Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.

→

secondary · POSTED

A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.

Eligible patients with available polymorphism and neutropenia toxicity data.

→

secondary · POSTED

A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.

Eligible patients with available polymorphism and thrombocytopenia toxicity data.

→

secondary · POSTED

A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.

Eligible patients with available polymorphism data and response data after two cycles of induction therapy. Measure value is the proportion of patients with a polymorphism.

→

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-primitive-neuroectodermal-tumor
nct id: NCT00567567
trial label: Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0000
source section id
NCT00567567-om-0000
source outcome index
0
endpoint
Event-free Survival Rate
endpoint definition
Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)
time origin
Three years, from time of randomization
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All eligible, randomized 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-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0001
source section id
NCT00567567-om-0001
source outcome index
1
endpoint
Response After Induction Therapy
endpoint definition
Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion (primary or metastases) with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive.
time origin
Study enrollment to the end of induction therapy
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients evaluated for response at the end of induction therapy.
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-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0002
source section id
NCT00567567-om-0002
source outcome index
2
endpoint
Incidence Rate of Local Recurrence
endpoint definition
Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.
time origin
Up to 3 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.
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-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0003
source section id
NCT00567567-om-0003
source outcome index
3
endpoint
Duration of Greater Than or Equal to Grade 3 Neutropenia
endpoint definition
A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.
time origin
Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with available polymorphism and neutropenia toxicity data.
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-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0004
source section id
NCT00567567-om-0004
source outcome index
4
endpoint
Duration of Greater Than or Equal to Grade 3 Thrombocytopenia
endpoint definition
A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.
time origin
Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with available polymorphism and thrombocytopenia toxicity data.
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-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0005
source section id
NCT00567567-om-0005
source outcome index
5
endpoint
Proportion of Patients With a Polymorphism
endpoint definition
A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.
time origin
Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with available polymorphism data and response data after two cycles of induction therapy. Measure value is the proportion of patients with a polymorphism.
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-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0000
arm key
OG000
arm label
Single HST (CEM)
regimen
Induction therapy + single myeloablative consolidation
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0000
arm key
OG001
arm label
Tandem HST (CEM), Randomly Assigned
regimen
Induction therapy + tandem myeloablative consolidation
analyzed count
176
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0001
arm key
OG000
arm label
Single HST (CEM)
regimen
Induction therapy + single myeloablative consolidation
analyzed count
206
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0001
arm key
OG001
arm label
Tandem HST (CEM), Randomly Assigned
regimen
Induction therapy + tandem myeloablative consolidation
analyzed count
176
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0001
arm key
OG002
arm label
Not Assigned
regimen
Patients that either failed during Induction therapy or refused randomization
analyzed count
233
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0002
arm key
OG000
arm label
Single HST (CEM)
regimen
Induction therapy + single myeloablative consolidation
analyzed count
77
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0003
arm key
OG000
arm label
Single HST (CEM)
regimen
Induction therapy + single myeloablative consolidation
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0003
arm key
OG001
arm label
Tandem HST (CEM), Randomly Assigned
regimen
Induction therapy + tandem myeloablative consolidation
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0003
arm key
OG002
arm label
Not Assigned
regimen
Patients that either failed during Induction therapy or refused randomization
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0004
arm key
OG000
arm label
Single HST (CEM)
regimen
Induction therapy + single myeloablative consolidation
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0004
arm key
OG001
arm label
Tandem HST (CEM), Randomly Assigned
regimen
Induction therapy + tandem myeloablative consolidation
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
outcome key
om-0004
arm key
OG002
arm label
Not Assigned
regimen
Patients that either failed during Induction therapy or refused randomization
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00567567-om-0004#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-primitive-neuroectodermal-tumor
nct id
NCT00567567
harm key
EG000
source section id
NCT00567567-ae
event group key
EG000
event group label
Single HST (CEM)
serious affected
16
serious at risk
206
other affected
196
other at risk
206
frequency threshold
0
collection period
Source null
event definition
We've excluded the ineligibles from this table.
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-primitive-neuroectodermal-tumor
nct id
NCT00567567
harm key
EG001
source section id
NCT00567567-ae
event group key
EG001
event group label
Tandem HST (CEM), Randomly Assigned
serious affected
15
serious at risk
176
other affected
163
other at risk
176
frequency threshold
0
collection period
Source null
event definition
We've excluded the ineligibles from this table.
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-primitive-neuroectodermal-tumor
nct id
NCT00567567
harm key
EG002
source section id
NCT00567567-ae
event group key
EG002
event group label
Not Assigned
serious affected
12
serious at risk
269
other affected
230
other at risk
269
frequency threshold
0
collection period
Source null
event definition
We've excluded the ineligibles from this table.
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