Trial · NCT00085202
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
NCT00085202, Phase 3, Completed, St. Jude Children's Research Hospital; results first posted 2014-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor. Trials, record NCT00085202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
- NCT number
- NCT00085202
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 416 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- filgrastim, cisplatin, cyclophosphamide, vincristine, autologous hematopoietic stem cell transplantation, radiation therapy
- First posted
- 2004-06-11
- Last updated
- 2024-02-08
- Results first posted
- 2014-02-27
- Limitations and caveats
The study participants for Secondary Outcome Measure #4 were randomized to standard-of-care group vs. reading intervention after medical treatment. The participants were a subset of patients who contributed to the primary aim and who signed a separate consent form distinct from the main medical treatment consent. They were then randomly assigned to either the standard-of-care group (SOC) or to the reading intervention (RI) group.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | 2 years after tumor cell analysis in 122 participants | 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. |
| Primary | Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | 2 years after tumor cell analysis in 122 participants | 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. |
| Primary | Frequency of Mutations Associated With SHH and WNT Tumors | within 3.5 years following completion of accrual | 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. |
| Secondary | Reading Decoding Composite Scores in the Intervention and Standard of Care Groups | 5 years postdiagnosis | 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). |
| Secondary | Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa | Annually for 6 years post irradiation | To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation. |
| Secondary | Associative Memory for Two Risk Group at Enrollment | At enrollment | 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. |
| Secondary | Associative Memory for Two Risk Group at 5 Years After Enrollment | At 5 years after enrollment | Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score 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. |
| Secondary | Processing Speed for Two Risk Group at Enrollment | At enrollment | Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better. |
| Secondary | Processing Speed for Two Risk Group at 5 Years After Enrollment | At 5 years after enrollment | Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better. |
| Secondary | Perceptual Speed for Two Risk Group at Enrollment | At enrollment | Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | 2 years after tumor cell analysis in 122 participants | 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. | probability of PFS at 2 years | NUMBER |
| PRIMARY | Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | 2 years after tumor cell analysis in 122 participants | 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. | probability of PFS at 2 years | NUMBER |
| PRIMARY | Frequency of Mutations Associated With SHH and WNT Tumors | within 3.5 years following completion of accrual | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Reading Decoding Composite Scores in the Intervention and Standard of Care Groups | 5 years postdiagnosis | 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. | score on a scale | MEAN |
| SECONDARY | Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa | Annually for 6 years post irradiation | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Associative Memory for Two Risk Group at Enrollment | At enrollment | 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. | score on a scale | MEAN |
| SECONDARY | Associative Memory for Two Risk Group at 5 Years After Enrollment | At 5 years after enrollment | 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. | score on a scale | MEAN |
| SECONDARY | Processing Speed for Two Risk Group at Enrollment | At enrollment | 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. | score on a scale | MEAN |
| SECONDARY | Processing Speed for Two Risk Group at 5 Years After Enrollment | At 5 years after enrollment | 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. | score on a scale | MEAN |
| SECONDARY | Perceptual Speed for Two Risk Group at Enrollment | At enrollment | 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. | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group195
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | Overall Study | Positive ERBB2 | 79.2 | 95% Confidence Interval 70.4 to 88.0 | probability of PFS at 2 years |
| Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | Average-Risk Group | Positive ERBB2 | 83.3 | 95% Confidence Interval 73.5 to 93.1 | probability of PFS at 2 years |
| Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | High-Risk Group | Positive ERBB2 | 69.6 | 95% Confidence Interval 50.8 to 88.4 | probability of PFS at 2 years |
| Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | Overall Study | Negative ERBB2 | 86.7 | 95% Confidence Interval 76.9 to 96.5 | probability of PFS at 2 years |
| Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | Average-Risk Group | Negative ERBB2 | 93.5 | 95% Confidence Interval 85.1 to 100 | probability of PFS at 2 years |
| Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | High-Risk Group | Negative ERBB2 | 71.4 | 95% Confidence Interval 48.9 to 93.9 | probability of PFS at 2 years |
| Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | ERBB2 Positive & Average Risk | 83.3 | 95% Confidence Interval 73.5 to 93.1 | probability of PFS at 2 years | |
| Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | ERBB2 Positive & High Risk | 69.6 | 95% Confidence Interval 50.8 to 88.4 | probability of PFS at 2 years | |
| Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | ERBB2 Negative & Average Risk | 93.5 | 95% Confidence Interval 85.1 to 100 | probability of PFS at 2 years | |
| Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | ERBB2 Negative & High Risk | 71.4 | 95% Confidence Interval 48.9 to 93.9 | probability of PFS at 2 years |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Average-Risk Group | 269 | |
| Overall Study | STARTED | High-Risk Group | 144 | |
| Overall Study | COMPLETED | Average-Risk Group | 251 | |
| Overall Study | COMPLETED | High-Risk Group | 120 | |
| Overall Study | NOT COMPLETED | Average-Risk Group | 18 | |
| Overall Study | NOT COMPLETED | High-Risk Group | 24 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Infections and infestations | Average-Risk Group | 172 | 269 | 383 |
| other | Febrile neutropenia | Infections and infestations | High-Risk Group | 77 | 144 | 148 |
| other | Infection, blood | Infections and infestations | Average-Risk Group | 55 | 269 | 76 |
| other | Infection, blood | Infections and infestations | High-Risk Group | 24 | 144 | 28 |
| other | Vomiting | Gastrointestinal disorders | Average-Risk Group | 53 | 269 | 63 |
| other | Vomiting | Gastrointestinal disorders | High-Risk Group | 21 | 144 | 29 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Average-Risk Group | 39 | 269 | 54 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | High-Risk Group | 23 | 144 | 32 |
| other | Pain, abdomen NOS | General disorders | Average-Risk Group | 33 | 269 | 37 |
| other | Pain, abdomen NOS | General disorders | High-Risk Group | 17 | 144 | 30 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Average-Risk Group | ||
| Total, all-cause mortality | High-Risk Group | ||
| Total, other adverse events | Average-Risk Group | 236 | 269 |
| Total, other adverse events | High-Risk Group | 118 | 144 |
| Total, serious adverse events | Average-Risk Group | 17 | 269 |
| Total, serious adverse events | High-Risk Group | 17 | 144 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Average-Risk Group vs High-Risk Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00085202
GET https://conductscience.org/api/trials/v1/NCT00085202/results?page=2