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← Oligoastrocytoma

NCT02372409 · STUDY IN CONTEXT

Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

PFS is followed from start of treatment to time of progression or death, whichever occurs first.

This outcome measure is for Arm A participants only.

→

primary · POSTED

Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 Years

This outcome measure is for Arm A participants only.

→

primary · POSTED

PFS is followed from start of treatment to time of progression or death, whichever occurs first.

This outcome measure is for Arm B participants only.

→

secondary · POSTED

Score ranges from 100% to 10%. A higher score indicates that the patient has a more normal quality of life.

This data was not collected on the patient from Arm B.

→

secondary · POSTED

* Arm A patients had blood drawn at the following time points: baseline, 3 days post-MLA, 2-4 weeks post-MLA, and every 12 weeks thereafter for 12 months post-MLA * Arm B patients had blood drawn at the following time points: baseline, 3 days post-MLA, week 1, week 2, week 3, week 4, week 5, week 6, and every 8 weeks for the first 2 years or until disease progression, whichever occurs first. * Neuron specific enolase is an enzyme involved in glycolysis, which is localized in neurons and axonal processes. Potentially, it escapes into the blood and CSF at the time of neural injury. Elevated serum NSE seemed to correlates with disruption in BBB following MLA and transient increase in BBB permeability.

The one participant in Arm B did not consent to any procedures past 12 months post-MLA. There are time points not included because either the NSE was not detected in the samples or the samples were not collected.

→

secondary · POSTED

* Arm A patients had blood drawn at the following time points: baseline, 3 days post-MLA, 2-4 weeks post-MLA, and every 12 weeks thereafter for 12 months post-MLA * Arm B patients had blood drawn at the following time points: baseline, 3 days post-MLA, week 1, week 2, week 3, week 4, week 5, week 6, and every 8 weeks for the first 2 years or until disease progression, whichever occurs first. * S100b is a low-molecular-weight Calcium-binding protein primarily found in astrocytic glial cells of the CNS. It is secreted by astrocytes for neuroprotective and -trophic cellular functions in the CNS. Elevated serum values can be associated with temporal changes in BBB integrity following MLA.

The one participant in Arm B did not consent to any procedures past 12 months post-MLA. There are time points not included because either the S100B was not detected in the samples or the samples were not collected.

→

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

Unnamed quality-of-life measure · Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status

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-oligoastrocytoma
nct id
NCT02372409
qol key
qol-0003
source section id
NCT02372409-om-0003
source outcome index
3
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status
measure definition
Score ranges from 100% to 10%. A higher score indicates that the patient has a more normal quality of life.
time frame
At 1 year post-MLA
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
This data was not collected on the patient from Arm B.
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-oligoastrocytoma
nct id
NCT02372409
trial label
Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0000
    source section id
    NCT02372409-om-0000
    source outcome index
    0
    endpoint
    Arm A Only: Number of Participants With Progression-free Survival (PFS)
    endpoint definition
    PFS is followed from start of treatment to time of progression or death, whichever occurs first.
    time origin
    Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure is for Arm A participants only.
    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-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0001
    source section id
    NCT02372409-om-0001
    source outcome index
    1
    endpoint
    Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 Years
    endpoint definition
    Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 Years
    time origin
    Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure is for Arm A participants only.
    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-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0002
    source section id
    NCT02372409-om-0002
    source outcome index
    2
    endpoint
    Arm B Only: Number of Participants With Progression-free Survival (PFS)
    endpoint definition
    PFS is followed from start of treatment to time of progression or death, whichever occurs first.
    time origin
    At 6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure is for Arm B participants only.
    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-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0003
    source section id
    NCT02372409-om-0003
    source outcome index
    3
    endpoint
    Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status
    endpoint definition
    Score ranges from 100% to 10%. A higher score indicates that the patient has a more normal quality of life.
    time origin
    At 1 year post-MLA
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This data was not collected on the patient from Arm B.
    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-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0004
    source section id
    NCT02372409-om-0004
    source outcome index
    4
    endpoint
    Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in Neuron-specific Enolase (NSE)
    endpoint definition
    * Arm A patients had blood drawn at the following time points: baseline, 3 days post-MLA, 2-4 weeks post-MLA, and every 12 weeks thereafter for 12 months post-MLA * Arm B patients had blood drawn at the following time points: baseline, 3 days post-MLA, week 1, week 2, week 3, week 4, week 5, week 6, and every 8 weeks for the first 2 years or until disease progression, whichever occurs first. * Neuron specific enolase is an enzyme involved in glycolysis, which is localized in neurons and axonal processes. Potentially, it escapes into the blood and CSF at the time of neural injury. Elevated serum NSE seemed to correlates with disruption in BBB following MLA and transient increase in BBB permeability.
    time origin
    Up to 48 weeks post MRI-guided laser heat ablation (Arm A) or up to 2 years post MRI-guided laser heat ablation (Arm B)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The one participant in Arm B did not consent to any procedures past 12 months post-MLA. There are time points not included because either the NSE was not detected in the samples or the samples were not collected.
    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-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0005
    source section id
    NCT02372409-om-0005
    source outcome index
    5
    endpoint
    Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in S100B
    endpoint definition
    * Arm A patients had blood drawn at the following time points: baseline, 3 days post-MLA, 2-4 weeks post-MLA, and every 12 weeks thereafter for 12 months post-MLA * Arm B patients had blood drawn at the following time points: baseline, 3 days post-MLA, week 1, week 2, week 3, week 4, week 5, week 6, and every 8 weeks for the first 2 years or until disease progression, whichever occurs first. * S100b is a low-molecular-weight Calcium-binding protein primarily found in astrocytic glial cells of the CNS. It is secreted by astrocytes for neuroprotective and -trophic cellular functions in the CNS. Elevated serum values can be associated with temporal changes in BBB integrity following MLA.
    time origin
    Up to 48 weeks post MRI-guided laser heat ablation (Arm A) or up to 2 years post MRI-guided laser heat ablation (Arm B)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The one participant in Arm B did not consent to any procedures past 12 months post-MLA. There are time points not included because either the S100B was not detected in the samples or the samples were not collected.
    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-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m\^2 over 5-30 minutes * Following the completion of doxorubin, etoposide 50 mg/m\^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m\^2 over 5-30 minutes * Following the completion of doxorubin, etoposide 50 mg/m\^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m\^2 over 5-30 minutes * Following the completion of doxorubin, etoposide 50 mg/m\^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Patient 1: Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Patient 2: Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Patient 3: Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0003#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0003
    arm key
    OG003
    arm label
    Patient 4: Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0003#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0003
    arm key
    OG004
    arm label
    Patient 5: Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0003#groups/OG004
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Patient 1: Arm A (MRI-guided Laser Ablation)
    regimen
    * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372409-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oligoastrocytoma
    nct id
    NCT02372409
    harm key
    EG000
    source section id
    NCT02372409-ae
    event group key
    EG000
    event group label
    Arm A (MRI-guided Laser Ablation)
    serious affected
    0
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    0
    collection period
    -Reportable adverse events will be tracked for 30 days following the last day of study treatment for patients in Arm B and for 30 days following the MLA for patients in Arm A. -All-cause mortality will be collected from start of treatment up to 5 years after start of treatment (median length of follow-up 413.5 days, full range 366 days-1801 days).
    event definition
    For patients in Arm A, adverse events (of any grade) considered possibly, probably, or definitely related to the MLA need be reported. Adverse events that are possibly, probably, or definitely related to study procedures will be followed until resolution or stabilization of the event. "Stabilization" is defined as remaining at a consistent CTCAE version 4.0 grade of the event for two consecutive assessments. For Arm B, all grade 3 and higher events regardless of attribution are to be reported.
    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-oligoastrocytoma
    nct id
    NCT02372409
    harm key
    EG001
    source section id
    NCT02372409-ae
    event group key
    EG001
    event group label
    Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
    serious affected
    0
    serious at risk
    1
    other affected
    0
    other at risk
    1
    frequency threshold
    0
    collection period
    -Reportable adverse events will be tracked for 30 days following the last day of study treatment for patients in Arm B and for 30 days following the MLA for patients in Arm A. -All-cause mortality will be collected from start of treatment up to 5 years after start of treatment (median length of follow-up 413.5 days, full range 366 days-1801 days).
    event definition
    For patients in Arm A, adverse events (of any grade) considered possibly, probably, or definitely related to the MLA need be reported. Adverse events that are possibly, probably, or definitely related to study procedures will be followed until resolution or stabilization of the event. "Stabilization" is defined as remaining at a consistent CTCAE version 4.0 grade of the event for two consecutive assessments. For Arm B, all grade 3 and higher events regardless of attribution are to be reported.
    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-oligoastrocytoma
    nct id
    NCT02372409
    qol key
    qol-0003
    source section id
    NCT02372409-om-0003
    source outcome index
    3
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status
    measure definition
    Score ranges from 100% to 10%. A higher score indicates that the patient has a more normal quality of life.
    time frame
    At 1 year post-MLA
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    This data was not collected on the patient from Arm B.
    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