NCT00085202 · STUDY IN CONTEXT

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

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 relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.

Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.

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primary · POSTED

122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.

Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.

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primary · POSTED

The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.

Only patients with WNT and SHH tumors with available tissue for targeted sequencing were analyzed for frequency of mutation. WNT and SHH subgroups were identified by methylation profiling.

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secondary · POSTED

SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).

Of the 126 MB patients enrolled, 41 were not eligible. This left 85 patients considered eligible for the randomization study. Of the 85 eligible patients,81 were randomized to either SOC (n= 38) or to RI (n =43). The parents of only four patients did not consent to the intervention study. Two patients randomized to the RI group, and four patients in the SOC group, were excluded due to having only a single assessment, which resulted in 75 patients (RI=41, SOC=34) over a 5-year follow-up period.

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secondary · POSTED

To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.

Analysis included 100 average risk participants with a diagnosis of medulloblastoma who had cumulative radiotherapy dose profiles and treatment failure volumes data available. All participants included in analysis who were still at risk and on-study were followed for a minimum of 6 years. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.

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secondary · POSTED

Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.

Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures ; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective.

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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-central-nervous-system-tumors
nct id: NCT00085202
trial label: Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0000
source section id
NCT00085202-om-0000
source outcome index
0
endpoint
Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors
endpoint definition
The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
time origin
2 years after tumor cell analysis in 122 participants
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.
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-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0001
source section id
NCT00085202-om-0001
source outcome index
1
endpoint
Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.
endpoint definition
122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
time origin
2 years after tumor cell analysis in 122 participants
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.
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-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0002
source section id
NCT00085202-om-0002
source outcome index
2
endpoint
Frequency of Mutations Associated With SHH and WNT Tumors
endpoint definition
The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.
time origin
within 3.5 years following completion of accrual
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only patients with WNT and SHH tumors with available tissue for targeted sequencing were analyzed for frequency of mutation. WNT and SHH subgroups were identified by methylation profiling.
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-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0003
source section id
NCT00085202-om-0003
source outcome index
3
endpoint
Reading Decoding Composite Scores in the Intervention and Standard of Care Groups
endpoint definition
SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).
time origin
5 years postdiagnosis
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of the 126 MB patients enrolled, 41 were not eligible. This left 85 patients considered eligible for the randomization study. Of the 85 eligible patients,81 were randomized to either SOC (n= 38) or to RI (n =43). The parents of only four patients did not consent to the intervention study. Two patients randomized to the RI group, and four patients in the SOC group, were excluded due to having only a single assessment, which resulted in 75 patients (RI=41, SOC=34) over a 5-year follow-up period.
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-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0004
source section id
NCT00085202-om-0004
source outcome index
4
endpoint
Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa
endpoint definition
To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.
time origin
Annually for 6 years post irradiation
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis included 100 average risk participants with a diagnosis of medulloblastoma who had cumulative radiotherapy dose profiles and treatment failure volumes data available. All participants included in analysis who were still at risk and on-study were followed for a minimum of 6 years. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.
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-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0005
source section id
NCT00085202-om-0005
source outcome index
5
endpoint
Associative Memory for Two Risk Group at Enrollment
endpoint definition
Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
time origin
At enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures ; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective.
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-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0000
arm key
OG000
arm label
Overall Study
regimen
Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
analyzed count
122
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0000
arm key
OG001
arm label
Average-Risk Group
regimen
Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \<1.5 cm\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \<1.5 cm\^2).
analyzed count
85
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0000
arm key
OG002
arm label
High-Risk Group
regimen
Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\^2) at the primary site after surgery.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0001
arm key
OG000
arm label
ERBB2 Positive & Average Risk
regimen
54 participants who were ERBB2 positive and in the average risk group.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0001
arm key
OG001
arm label
ERBB2 Positive & High Risk
regimen
23 participants who were ERBB2 positive and in the high risk group
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0001
arm key
OG002
arm label
ERBB2 Negative & Average Risk
regimen
31 participants who were ERBB2 negative and in the average risk group
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0001
arm key
OG003
arm label
ERBB2 Negative & High Risk
regimen
14 participants who were ERBB2 negative and in the high risk group
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0002
arm key
OG000
arm label
SHH Pathway - In/Del Somatic
regimen
Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0002
arm key
OG001
arm label
WNT Pathway - In/Del Somatic
regimen
Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0002
arm key
OG002
arm label
SHH Pathway - In/Del Germline
regimen
Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0002
arm key
OG003
arm label
WNT Pathway - In/Del Germline
regimen
Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
outcome key
om-0002
arm key
OG004
arm label
SHH Pathway - SNV Somatic
regimen
Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV).
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00085202-om-0002#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00085202
harm key
EG000
source section id
NCT00085202-ae
event group key
EG000
event group label
Average-Risk Group
serious affected
17
serious at risk
269
other affected
236
other at risk
269
frequency threshold
5
collection period
Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.
event definition
Per protocol, Grade 3 and 4 hematologic toxicities, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected if they occurred from the beginning of radiation therapy through the end of 4 courses of high dose chemotherapy.
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-central-nervous-system-tumors
nct id
NCT00085202
harm key
EG001
source section id
NCT00085202-ae
event group key
EG001
event group label
High-Risk Group
serious affected
17
serious at risk
144
other affected
118
other at risk
144
frequency threshold
5
collection period
Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.
event definition
Per protocol, Grade 3 and 4 hematologic toxicities, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected if they occurred from the beginning of radiation therapy through the end of 4 courses of high dose chemotherapy.
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