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← Neuroblastoma

NCT00499616 · STUDY IN CONTEXT

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With 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. 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

OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.

Eligible intermediate risk patients.

→

primary · POSTED

Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q.

Eligible intermediate risk patients with 1p and 11q data.

→

primary · POSTED

Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age.

Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.

→

primary · POSTED

Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age

Eligible and evaluable patients with Stage 3 neuroblastoma, 12-18 months of age, MYCN non-amplified, and unfavorable histology.

→

primary · POSTED

Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event.

Eligible and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection.

→

primary · POSTED

Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy.

Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy.

→

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

FACT · Image Defined Risk Factor (IDRF)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00499616
qol key
qol-0014
source section id
NCT00499616-om-0014
source outcome index
14
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Image Defined Risk Factor (IDRF)
measure definition
Percentage of patients with presence of one or more IDRFs will be calculated. IDRFs describe anatomic features which may make surgical resection more difficult.
time frame
At baseline
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All eligible and evaluable patients enrolled on ANBL0531
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT00499616
trial label
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With 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.
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
4
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0000
    source section id
    NCT00499616-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS) Rates
    endpoint definition
    OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.
    time origin
    3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible intermediate risk patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0001
    source section id
    NCT00499616-om-0001
    source outcome index
    1
    endpoint
    Definitive Determination of the Prognostic Ability of 1p and 11q
    endpoint definition
    Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q.
    time origin
    At baseline
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible intermediate risk patients with 1p and 11q data.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0002
    source section id
    NCT00499616-om-0002
    source outcome index
    2
    endpoint
    Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961
    endpoint definition
    Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age.
    time origin
    Up to 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0003
    source section id
    NCT00499616-om-0003
    source outcome index
    3
    endpoint
    Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961
    endpoint definition
    Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age
    time origin
    Up to 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable patients with Stage 3 neuroblastoma, 12-18 months of age, MYCN non-amplified, and unfavorable histology.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0004
    source section id
    NCT00499616-om-0004
    source outcome index
    4
    endpoint
    Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma
    endpoint definition
    Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event.
    time origin
    Up to 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0005
    source section id
    NCT00499616-om-0005
    source outcome index
    5
    endpoint
    Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment
    endpoint definition
    Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy.
    time origin
    From baseline to up to 10 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Group 2 (Chemotherapy, Surgery)
    regimen
    2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Group 3 (Chemotherapy, Surgery)
    regimen
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    140
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
    regimen
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    89
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Group 2 (Chemotherapy, Surgery)
    regimen
    2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Group 3 (Chemotherapy, Surgery)
    regimen
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    104
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
    regimen
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    62
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Group 3 (Chemotherapy, Surgery)
    regimen
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
    regimen
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Group 3 (Chemotherapy, Surgery)
    regimen
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0003#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
    regimen
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0003#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Group 2 (Chemotherapy, Surgery)
    regimen
    2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Group 3 (Chemotherapy, Surgery)
    regimen
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00499616-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    harm key
    EG000
    source section id
    NCT00499616-ae
    event group key
    EG000
    event group label
    Group 2 (Chemotherapy, Surgery)
    serious affected
    2
    serious at risk
    175
    other affected
    135
    other at risk
    175
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    harm key
    EG001
    source section id
    NCT00499616-ae
    event group key
    EG001
    event group label
    Group 3 (Chemotherapy, Surgery)
    serious affected
    5
    serious at risk
    140
    other affected
    114
    other at risk
    140
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    harm key
    EG002
    source section id
    NCT00499616-ae
    event group key
    EG002
    event group label
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
    serious affected
    8
    serious at risk
    89
    other affected
    76
    other at risk
    89
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    harm key
    EG003
    source section id
    NCT00499616-ae
    event group key
    EG003
    event group label
    Non-intermediate Risk Enrolled on Intermediate Risk Trial
    serious affected
    1
    serious at risk
    42
    other affected
    23
    other at risk
    42
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroblastoma
    nct id
    NCT00499616
    qol key
    qol-0014
    source section id
    NCT00499616-om-0014
    source outcome index
    14
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Image Defined Risk Factor (IDRF)
    measure definition
    Percentage of patients with presence of one or more IDRFs will be calculated. IDRFs describe anatomic features which may make surgical resection more difficult.
    time frame
    At baseline
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All eligible and evaluable patients enrolled on ANBL0531
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice