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← Retinoblastoma

NCT00554788 · STUDY IN CONTEXT

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

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 probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause.

Ineligible patients were excluded from analysis

→

secondary · POSTED

This study used a modified version of the international criteria for neuroblastoma response. The response rate to the induction phase of the regimen and a corresponding 95% confidence interval will be calculated for all strata combined.

Ineligible patients were excluded from analysis

→

secondary · POSTED

Grade 3 and higher toxicities will be descriptively summarized.

Three ineligible patients were excluded from this analysis. Two patients who did not receive therapy were also excluded from this analysis.

→

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-retinoblastoma
nct id
NCT00554788
trial label
Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma
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
3
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0000
    source section id
    NCT00554788-om-0000
    source outcome index
    0
    endpoint
    Event-free Survival (EFS)
    endpoint definition
    The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause.
    time origin
    At 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible patients were excluded from analysis
    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-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0001
    source section id
    NCT00554788-om-0001
    source outcome index
    1
    endpoint
    Response Rate to the Induction Phase of the Regimen
    endpoint definition
    This study used a modified version of the international criteria for neuroblastoma response. The response rate to the induction phase of the regimen and a corresponding 95% confidence interval will be calculated for all strata combined.
    time origin
    12 weeks after participant received the first dose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Ineligible patients were excluded from analysis
    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-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0002
    source section id
    NCT00554788-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
    endpoint definition
    Grade 3 and higher toxicities will be descriptively summarized.
    time origin
    Up to 30 days after completion of study treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Three ineligible patients were excluded from this analysis. Two patients who did not receive therapy were also excluded from this analysis.
    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-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Stage 2/3 Patients
    regimen
    Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00554788-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Stage 4a Patients
    regimen
    Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00554788-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Stage 4b Patients
    regimen
    Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00554788-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0001
    arm key
    OG000
    arm label
    All Eligible Patients
    regimen
    All eligible Stage 2/3, Stage 4a, and Stage 4b patients
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00554788-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Stage 2/3 Patients
    regimen
    Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00554788-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Stage 4a Patients
    regimen
    Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00554788-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Stage 4b Patients
    regimen
    Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00554788-om-0002#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT00554788
    harm key
    EG000
    source section id
    NCT00554788-ae
    event group key
    EG000
    event group label
    Stage 2/3 Patients
    serious affected
    1
    serious at risk
    18
    other affected
    13
    other at risk
    18
    frequency threshold
    0
    collection period
    Up to 30 days after completion of study treatment.
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    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-retinoblastoma
    nct id
    NCT00554788
    harm key
    EG001
    source section id
    NCT00554788-ae
    event group key
    EG001
    event group label
    Stage 4a Patients
    serious affected
    2
    serious at risk
    18
    other affected
    12
    other at risk
    18
    frequency threshold
    0
    collection period
    Up to 30 days after completion of study treatment.
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    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-retinoblastoma
    nct id
    NCT00554788
    harm key
    EG002
    source section id
    NCT00554788-ae
    event group key
    EG002
    event group label
    Stage 4b Patients
    serious affected
    0
    serious at risk
    19
    other affected
    10
    other at risk
    19
    frequency threshold
    0
    collection period
    Up to 30 days after completion of study treatment.
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    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