Trial · NCT00392327
Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET
NCT00392327, Phase 3, Completed, Children's Oncology Group; results first posted 2020-08-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET. Trials, record NCT00392327. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00392327
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET
- NCT number
- NCT00392327
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 379 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Anaplastic Medulloblastoma, Medulloblastoma
- Interventions
Biospecimen Collection, Carboplatin, Cisplatin, Cyclophosphamide, Filgrastim, Isotretinoin, Lumbar Puncture, Magnetic Resonance Imaging, Quality-of-Life Assessment, Radiation Therapy, Vincristine Sulfate
- First posted
- 2006-10-26
- Last updated
- 2026-06-08
- Results first posted
- 2020-08-07
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma | Up to 5 years | The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined. |
| Primary | Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Up to 5 years | The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. |
| Secondary | Tumor Response to Radiation Therapy for Patients With Medulloblastoma | 12 weeks after treatment initiation | Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses. |
| Secondary | Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | 12 weeks after treatment initiation | Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses. SPNET is no longer recognized by WHO (World Health Organization) as a disease entity. Additional trial information can be found under PubMed® # 30332335. |
| Secondary | Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma | Up to 5 years | The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined. |
| Secondary | Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Up to 5 years | The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact. |
| Secondary | The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients | 6 - 12 months post diagnosis | Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. |
| Secondary | The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients | 24 - 36 months post diagnosis | Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 30+/-6 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. |
| Secondary | The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for Medulloblastoma Patients | 48 - 72 months post diagnosis | Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 60+/-12 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. |
| Secondary | The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients | 6 - 12 months post diagnosis | Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma | Up to 5 years | Eligible medulloblastoma patients are included. | Percent Probability | NUMBER |
| PRIMARY | Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Up to 5 years | Eligible SPNET patients are included. | Percent Probability | NUMBER |
| SECONDARY | Tumor Response to Radiation Therapy for Patients With Medulloblastoma | 12 weeks after treatment initiation | 83 of 87 eligible Arm A medulloblastoma patients were evaluated for response after induction, as were 85/89, 48/53, and 55/56 arm B, C, and D patients, respectively. | percentage of patients | NUMBER |
| SECONDARY | Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | 12 weeks after treatment initiation | 23 of 23 eligible Arm A SPNET patients were evaluated for response after induction, as were 18/19, 21/21, and 19/22 arm B, C, and D patients, respectively. | percentage of patients | NUMBER |
| SECONDARY | Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma | Up to 5 years | Eligible medulloblastoma patients are included. | Percent Probability | NUMBER |
| SECONDARY | Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Up to 5 years | Eligible SPNET patients are included. | Percent Probability | NUMBER |
| SECONDARY | The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients | 6 - 12 months post diagnosis | Eligible medulloblastoma patients are included. | Score on a scale | MEAN |
| SECONDARY | The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients | 24 - 36 months post diagnosis | |||
| SECONDARY | The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for Medulloblastoma Patients | 48 - 72 months post diagnosis | |||
| SECONDARY | The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients | 6 - 12 months post diagnosis | Eligible SPNET patients are included. | Score on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma | Regimen A (Medulloblastoma Patients) | 57.5 | 95% Confidence Interval 43.6 to 71.4 | Percent Probability | |
| Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma | Regimen B (Medulloblastoma Patients) | 65.3 | 95% Confidence Interval 52.0 to 78.6 | Percent Probability | |
| Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma | Regimen C (Medulloblastoma Patients) | 60.3 | 95% Confidence Interval 47.0 to 73.6 | Percent Probability | |
| Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma | Regimen D (Medulloblastoma Patients) | 70.9 | 95% Confidence Interval 57.8 to 84.0 | Percent Probability | |
| Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Regimen A (SPNET Patients) | 52.2 | 95% Confidence Interval 32.6 to 71.8 | Percent Probability | |
| Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Regimen B (SPNET Patients) | 52.6 | 95% Confidence Interval 31.2 to 74.0 | Percent Probability | |
| Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Regimen C (SPNET Patients) | 19 | 95% Confidence Interval 3.9 to 34.1 | Percent Probability | |
| Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) | Regimen D (SPNET Patients) | 63 | 95% Confidence Interval 43.0 to 83.0 | Percent Probability | |
| Tumor Response to Radiation Therapy for Patients With Medulloblastoma | Regimen A (Medulloblastoma Patients) | 75.9 | 95% Confidence Interval 65.3 to 84.6 | percentage of patients | |
| Tumor Response to Radiation Therapy for Patients With Medulloblastoma | Regimen B (Medulloblastoma Patients) | 78.8 | 95% Confidence Interval 68.6 to 86.9 | percentage of patients |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen A (Medulloblastoma Patients) | 87 | |
| Overall Study | STARTED | Regimen B (Medulloblastoma Patients) | 93 | |
| Overall Study | STARTED | Regimen C (Medulloblastoma Patients) | 56 | |
| Overall Study | STARTED | Regimen D (Medulloblastoma Patients) | 58 | |
| Overall Study | STARTED | Regimen A (SPNET Patients) | 23 | |
| Overall Study | STARTED | Regimen B (SPNET Patients) | 19 | |
| Overall Study | STARTED | Regimen C (SPNET Patients) | 21 | |
| Overall Study | STARTED | Regimen D (SPNET Patients) | 22 | |
| Overall Study | COMPLETED | Regimen A (Medulloblastoma Patients) | 72 | |
| Overall Study | COMPLETED | Regimen B (Medulloblastoma Patients) | 74 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,760
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 | Neutrophil count decreased | Investigations | Regimen A (Medulloblastoma Patients) | 52 | 87 | 113 |
| other | Neutrophil count decreased | Investigations | Regimen B (Medulloblastoma Patients) | 59 | 89 | 143 |
| other | Neutrophil count decreased | Investigations | Regimen C (Medulloblastoma Patients) | 38 | 53 | 82 |
| other | Neutrophil count decreased | Investigations | Regimen D (Medulloblastoma Patients) | 40 | 56 | 99 |
| other | Neutrophil count decreased | Investigations | Regimen A (SPNET Patients) | 14 | 23 | 31 |
| other | Neutrophil count decreased | Investigations | Regimen B (SPNET Patients) | 16 | 19 | 43 |
| other | Neutrophil count decreased | Investigations | Regimen C (SPNET Patients) | 11 | 21 | 21 |
| other | Neutrophil count decreased | Investigations | Regimen D (SPNET Patients) | 16 | 22 | 35 |
| other | White blood cell decreased | Investigations | Regimen A (Medulloblastoma Patients) | 49 | 87 | 116 |
| other | White blood cell decreased | Investigations | Regimen B (Medulloblastoma Patients) | 53 | 89 | 124 |
1 to 10 of 1,760Source ClinicalTrials.gov
See all 1,760 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen A (Medulloblastoma Patients) | 24 | 87 |
| Total, all-cause mortality | Regimen B (Medulloblastoma Patients) | 23 | 89 |
| Total, all-cause mortality | Regimen C (Medulloblastoma Patients) | 22 | 53 |
| Total, all-cause mortality | Regimen D (Medulloblastoma Patients) | 16 | 56 |
| Total, all-cause mortality | Regimen A (SPNET Patients) | 11 | 23 |
| Total, all-cause mortality | Regimen B (SPNET Patients) | 8 | 19 |
| Total, all-cause mortality | Regimen C (SPNET Patients) | 14 | 21 |
| Total, all-cause mortality | Regimen D (SPNET Patients) | 8 | 22 |
| Total, other adverse events | Regimen A (Medulloblastoma Patients) | 72 | 87 |
| Total, other adverse events | Regimen B (Medulloblastoma Patients) | 80 | 89 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| R01CA114567 | Targeted Therapy in Ex Vivo Medulloblastoma | OLSON, JAMES M | SEATTLE CHILDREN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 2006 to 2023 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00392327
GET https://conductscience.org/api/trials/v1/NCT00392327/results?page=2