Trial · NCT00085735
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
NCT00085735, Phase 3, Completed, Children's Oncology Group; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma. Trials, record NCT00085735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085735
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
- NCT number
- NCT00085735
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 549 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Medulloblastoma
- Interventions
- Cisplatin, Craniospinal Irradiation, Cyclophosphamide, Involved-Field Radiation Therapy, Laboratory Biomarker Analysis, Lomustine, Quality-of-Life Assessment, Radiation Therapy, Vincristine Sulfate
- First posted
- 2004-06-16
- Last updated
- 2026-06-09
- Results first posted
- 2017-06-14
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | Assessed at 3 years | EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's). |
| Primary | Overall Survival (OS) | 3 years | OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy \[IFRT\]) are combined and compared to arms II, IV and VI (posterior fossa irradiation \[PFRT\]). |
| Secondary | Local Posterior Fossa (LPF) Failure Rate | 3 years | LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events. |
| Secondary | Non-local Posterior Fossa (NLPF) Failure Rate | 3 years | NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events. |
| Secondary | Non-posterior Fossa (NPF) Failure Rate | 3 years | NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events. |
| Secondary | Post-treatment Endocrine Function by CSI Group | Up to 3 years | Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported. |
| Secondary | Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4 | Up to 3 years | Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used. |
| Secondary | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis). | 4 -15 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 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. |
| Secondary | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis) | 27 - 48 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 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better. |
| Secondary | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis) | 49 - 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 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) | Assessed at 3 years | Per protocol only eligible \& evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison. | probability of 3 year EFS | NUMBER |
| PRIMARY | Overall Survival (OS) | 3 years | Per protocol only eligible \& evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison. | Probability of 3 yr OS rate | NUMBER |
| SECONDARY | Local Posterior Fossa (LPF) Failure Rate | 3 years | Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \[IFRT\] are combined \& arms II/IV/VI \[PFRT\] are combined. 26 \& 23 IFRT \& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts. | percentage 3 yr cumulative incidence | NUMBER |
| SECONDARY | Non-local Posterior Fossa (NLPF) Failure Rate | 3 years | Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \[IFRT\] are combined \& arms II/IV/VI \[PFRT\] are combined. 26 \& 23 IFRT \& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts. | Percentage of 3 yr cumulative incidence | NUMBER |
| SECONDARY | Non-posterior Fossa (NPF) Failure Rate | 3 years | Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \[IFRT\] are combined \& arms II/IV/VI \[PFRT\] are combined. 26 \& 23 IFRT \& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts. | Percentage of 3 yr cumulative incidence | NUMBER |
| SECONDARY | Post-treatment Endocrine Function by CSI Group | Up to 3 years | Only eligible \& evaluable pts 3-7 years of age were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 11 and 8 LDSCI and SDCSI pts were NE, respectively, leaving 116 vs 110 for this comparison. Of these, 89 LDSCI and 79 SDCSI pts had post-treatment TSH values available and were included. | uU/ml | MEAN |
| SECONDARY | Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4 | Up to 3 years | Only eligible \& evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis. | Percentage of pts with g3+ hearing loss | NUMBER |
| SECONDARY | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis). | 4 -15 months post diagnosis | Only eligible \& evaluable patients 3-7 years of age with FSIQ observations within time window were included. | Scores on a scale | MEAN |
| SECONDARY | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis) | 27 - 48 months post diagnosis | Only eligible \& evaluable patients 3-7 years of age with FSIQ observations within time window were included. | Scores on a scale | MEAN |
| SECONDARY | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis) | 49 - 72 months post diagnosis | Eligible and evaluable patients are reported. | Scores on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) | Low-dose Craniospinal Radiation (LDSCI) | LDCSI vs SDCSI | 76.3 | 95% Confidence Interval 67.9 to 84.7 | probability of 3 year EFS |
| Event-free Survival (EFS) | Standard-dose Craniospinal Radiation (SDCSI) | LDCSI vs SDCSI | 84.9 | 95% Confidence Interval 77.6 to 92.2 | probability of 3 year EFS |
| Event-free Survival (EFS) | Involved Field Radiation (IFRT) | IFRT vs PFRT | 85.8 | 95% Confidence Interval 81.1 to 90.5 | probability of 3 year EFS |
| Event-free Survival (EFS) | Posterior Fossa Radiation (PFRT) | IFRT vs PFRT | 85.8 | 95% Confidence Interval 81.1 to 90.5 | probability of 3 year EFS |
| Overall Survival (OS) | Involved Field Radiation (IFRT) | IFRT vs PFRT | 90.3 | 95% Confidence Interval 86.2 to 94.4 | Probability of 3 yr OS rate |
| Overall Survival (OS) | Posterior Fossa Radiation (PFRT) | IFRT vs PFRT | 93.3 | 95% Confidence Interval 90.0 to 96.6 | Probability of 3 yr OS rate |
| Overall Survival (OS) | Low-dose Craniospinal Radiation (LDSCI) | LDCSI vs SDCSI | 85.5 | 95% Confidence Interval 78.4 to 92.6 | Probability of 3 yr OS rate |
| Overall Survival (OS) | Standard-dose Craniospinal Radiation (SDCSI) | LDCSI vs SDCSI | 90.4 | 95% Confidence Interval 84.3 to 96.5 | Probability of 3 yr OS rate |
| Local Posterior Fossa (LPF) Failure Rate | Involved Field Radiation (IFRT) | 1.4 | 95% Confidence Interval 0.0 to 2.89 | percentage 3 yr cumulative incidence | |
| Local Posterior Fossa (LPF) Failure Rate | Posterior Fossa Radiation (PFRT) | 2.7 | 95% Confidence Interval 0.6 to 4.9 | percentage 3 yr cumulative incidence |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (3-7 Yrs of Age, LDCSI, IFRT) | 64 | |
| Overall Study | STARTED | Arm II (3-7 Yrs of Age, LDCSI, PFRT) | 64 | |
| Overall Study | STARTED | Arm III (3-7 Yrs of Age, SDCSI, IFRT) | 63 | |
| Overall Study | STARTED | Arm IV (3-7 Yrs of Age, SDCSI, PFRT) | 65 | |
| Overall Study | STARTED | Arm V (8-21 Yrs of Age, SDCSI, IFRT) | 147 | |
| Overall Study | STARTED | Arm VI (8-21 Yrs of Age, SDCSI, PFRT) | 146 | |
| Overall Study | COMPLETED | Arm I (3-7 Yrs of Age, LDCSI, IFRT) | 52 | |
| Overall Study | COMPLETED | Arm II (3-7 Yrs of Age, LDCSI, PFRT) | 54 | |
| Overall Study | COMPLETED | Arm III (3-7 Yrs of Age, SDCSI, IFRT) | 46 | |
| Overall Study | COMPLETED | Arm IV (3-7 Yrs of Age, SDCSI, PFRT) | 46 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,710
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 | Anemia | Blood and lymphatic system disorders | Arm I (3-7 Years of Age, LDCSI, IFRT) | 30 | 63 | 109 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (3-7 Years of Age, LDCSI, PFRT) | 30 | 64 | 117 |
| other | Anemia | Blood and lymphatic system disorders | Arm III (3-7 Years of Age, SDCSI, IFRT) | 24 | 60 | 125 |
| other | Anemia | Blood and lymphatic system disorders | Arm IV (3-7 Years of Age, SDCSI, PFRT) | 27 | 58 | 104 |
| other | Anemia | Blood and lymphatic system disorders | Arm V (8-21 Years of Age, SDCSI, IFRT) | 62 | 130 | 278 |
| other | Anemia | Blood and lymphatic system disorders | Arm VI (8-21 Years of Age, SDCSI, PFRT) | 55 | 138 | 203 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I (3-7 Years of Age, LDCSI, IFRT) | 0 | 63 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm II (3-7 Years of Age, LDCSI, PFRT) | 1 | 64 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm III (3-7 Years of Age, SDCSI, IFRT) | 0 | 60 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm IV (3-7 Years of Age, SDCSI, PFRT) | 0 | 58 | 0 |
1 to 10 of 1,710Source ClinicalTrials.gov
See all 1,710 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (3-7 Years of Age, LDCSI, IFRT) | ||
| Total, all-cause mortality | Arm II (3-7 Years of Age, LDCSI, PFRT) | ||
| Total, all-cause mortality | Arm III (3-7 Years of Age, SDCSI, IFRT) | ||
| Total, all-cause mortality | Arm IV (3-7 Years of Age, SDCSI, PFRT) | ||
| Total, all-cause mortality | Arm V (8-21 Years of Age, SDCSI, IFRT) | ||
| Total, all-cause mortality | Arm VI (8-21 Years of Age, SDCSI, PFRT) | ||
| Total, other adverse events | Arm I (3-7 Years of Age, LDCSI, IFRT) | 60 | 63 |
| Total, other adverse events | Arm II (3-7 Years of Age, LDCSI, PFRT) | 61 | 64 |
| Total, other adverse events | Arm III (3-7 Years of Age, SDCSI, IFRT) | 55 | 60 |
| Total, other adverse events | Arm IV (3-7 Years of Age, SDCSI, PFRT) | 53 | 58 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34110925 | DERIVED |
Source PubMed
Grants2
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 |
| 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
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