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← Childhood Hodgkin Lymphoma

NCT00302003 · STUDY IN CONTEXT

Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma

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

Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).

Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).

→

primary · POSTED

Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC\* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.

Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).

→

primary · POSTED

Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).

Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).

→

secondary · POSTED

Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.

Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).

→

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-hodgkin-lymphoma-pediatric
nct id
NCT00302003
trial label
Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma
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
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0000
    source section id
    NCT00302003-om-0000
    source outcome index
    0
    endpoint
    Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
    endpoint definition
    Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).
    time origin
    At 60 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).
    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-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0001
    source section id
    NCT00302003-om-0001
    source outcome index
    1
    endpoint
    Intensive Therapy Free Survival (ITFS).
    endpoint definition
    Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC\* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
    time origin
    At 60 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).
    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-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0002
    source section id
    NCT00302003-om-0002
    source outcome index
    2
    endpoint
    Event Free Survival (EFS)
    endpoint definition
    Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).
    time origin
    At 60 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).
    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-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0003
    source section id
    NCT00302003-om-0003
    source outcome index
    3
    endpoint
    Overall Survival
    endpoint definition
    Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.
    time origin
    At 60 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).
    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-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Group 1
    regimen
    Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
    analyzed count
    275
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00302003-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Group 1
    regimen
    Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
    analyzed count
    275
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00302003-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Group 1
    regimen
    Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
    analyzed count
    278
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00302003-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Group 1
    regimen
    Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
    analyzed count
    278
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00302003-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT00302003
    harm key
    EG000
    source section id
    NCT00302003-ae
    event group key
    EG000
    event group label
    Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
    serious affected
    2
    serious at risk
    278
    other affected
    80
    other at risk
    278
    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