Trial · NCT00336024
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
NCT00336024, Phase 3, Completed, Children's Oncology Group; results first posted 2018-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma. Trials, record NCT00336024. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00336024
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
- NCT number
- NCT00336024
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Anaplastic Medulloblastoma, Medulloblastoma, Supratentorial Embryonal Tumor, Not Otherwise Specified, Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
- Interventions
Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, Cisplatin, Cyclophosphamide, Etoposide, Filgrastim, Laboratory Biomarker Analysis, Leucovorin Calcium, Methotrexate, Quality-of-Life Assessment, Thiotepa, Vincristine Sulfate
- First posted
- 2006-06-12
- Last updated
- 2026-01-23
- Results first posted
- 2018-10-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate | At the end of consolidation treatment | At the end of consolidation, the number of evaluable patients treated with intensive chemotherapy with methotrexate who achieved CR or not will be compared to those who achieved CR or not after treated with the same intensive chemotherapy without methotrexate. The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test. Complete Response (CR) requires: CR for target lesions: disappearance of all target lesions, CR for non-target lesions: disappearance of all non-target lesions and no new lesions. No CR is any response not fitting the definition of CR. |
| Secondary | Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | At baseline | The number of patients will be reported for this analysis by Molecular Sub-types of MB, CNS-PNETs/EBTs |
| Secondary | Percentage of Participants With Event Free Survival (EFS) | Baseline to up to 5 years | EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 80% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1. |
| Secondary | Patterns of Failure | Baseline to up to 5 years | The patterns of failure for relapse/disease progression will be provided for patients treated with/without methotrexate drug in three categories, namely local, distant, and both local and distant. The number of patients with each type of failure will be listed per arm. The two groups will be compared to determine if the pattern of failure distribution is different between the two arms using Fisher exact test. |
| Secondary | Percentage of Participants With Any Acute Adverse Events | Beginning of treatment to the end of consolidation | Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test. |
| Secondary | Number of Participants With Acute Hearing Loss and No Acute Hearing Loss | Beginning of treatment to the end of consolidation | Per protocol, hearing was assessed pretreatment and at regular specified intervals during treatment and off therapy, using DPOAE, audiogram or Brainstem Evoked Auditory. Per CTCAE V4.0 grade 3 Hearing impaired is defined as follows; Pediatric (on a 1,2,3,4, 6 and 8 kHz audiogram): hearing loss sufficient to indicate therapeutic intervention, including hearing aids, threshold shift \>20 dB at 3 kHz and above in at least one ear, additional speech-language related services as indicated. Per CTCAE V4.0 grade 4 Hearing impaired is defined as follows; Pediatric Audiologic indication for cochlear implant and additional speech-language related services as indicated. |
| Secondary | Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism | Off-treatment up to 9 years | Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. "Normal" and "Abnormal" are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than "Institutional" Normal or equal to "Institutional" Normal with TSH level greater than "Institutional" Normal. |
| Secondary | Number of Participants With Chronic Central Hypothyroidism | Off-treatment up to 9 years | Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. "Normal" and "Abnormal" are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than "Institutional" Normal with TSH less than or equal to "Institutional" Normal. |
| Secondary | Number of Participants With Chronic Low Somatomedin C | Off-treatment up to 9 years | Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run. |
| Secondary | Number of Participants With Chronic Diabetes Insipidus | Beginning of off-treatment to up to 9 years | The number of patients who had "Diabetes Insipidus" and on DDAVP will be reported for this analysis due to small numbers.. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate | At the end of consolidation treatment | Per protocol, only evaluable patients are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | At baseline | 13 patients without molecular data, because of lack of sufficient materials or poor quality of the data, were not included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Event Free Survival (EFS) | Baseline to up to 5 years | Per protocol all eligible patients randomized to treatment should be included in the analysis. | percentage of participants with EFS | NUMBER |
| SECONDARY | Patterns of Failure | Baseline to up to 5 years | All Eligible Participants who relapsed/disease progressed in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Any Acute Adverse Events | Beginning of treatment to the end of consolidation | Per protocol all eligible patients randomized to treatment should be included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Acute Hearing Loss and No Acute Hearing Loss | Beginning of treatment to the end of consolidation | Per protocol all eligible patients randomized to treatment should be included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism | Off-treatment up to 9 years | Per protocol all eligible patients randomized to treatment should be included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chronic Central Hypothyroidism | Off-treatment up to 9 years | Per protocol all eligible patients randomized to treatment should be included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chronic Low Somatomedin C | Off-treatment up to 9 years | Per protocol all eligible patients randomized to treatment should be included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chronic Diabetes Insipidus | Beginning of off-treatment to up to 9 years | Per protocol all eligible patients randomized to treatment should be included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate | Arm I (Patients Treated Without Methotrexate (MTX)) | Complete response | 13 | Participants | |
| Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate | Arm II (Patients Treated With MTX) | Complete response | 15 | Participants | |
| Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate | Arm I (Patients Treated Without Methotrexate (MTX)) | No Complete response | 16 | Participants | |
| Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate | Arm II (Patients Treated With MTX) | No Complete response | 15 | Participants | |
| Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | Arm I (Patients Treated Without Methotrexate (MTX)) | Medulloblastoma, sonic hedgehog subgroup | 5 | Participants | |
| Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | Arm II (Patients Treated With MTX) | Medulloblastoma, sonic hedgehog subgroup | 6 | Participants | |
| Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | Arm I (Patients Treated Without Methotrexate (MTX)) | Medulloblastoma, group 3 subgroup | 15 | Participants | |
| Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | Arm II (Patients Treated With MTX) | Medulloblastoma, group 3 subgroup | 10 | Participants | |
| Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | Arm I (Patients Treated Without Methotrexate (MTX)) | Medulloblastoma, group 4 subgroup | 0 | Participants | |
| Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort | Arm II (Patients Treated With MTX) | Medulloblastoma, group 4 subgroup | 2 | Participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Patients Treated Without Methotrexate (MTX)) | 46 | |
| Overall Study | STARTED | Arm II (Patients Treated With MTX) | 45 | |
| Overall Study | COMPLETED | Arm I (Patients Treated Without Methotrexate (MTX)) | 26 | |
| Overall Study | COMPLETED | Arm II (Patients Treated With MTX) | 26 | |
| Overall Study | NOT COMPLETED | Arm I (Patients Treated Without Methotrexate (MTX)) | 20 | |
| Overall Study | NOT COMPLETED | Arm II (Patients Treated With MTX) | 19 |
Source ClinicalTrials.gov
Adverse events278
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 (Patients Treated Without Methotrexate (MTX)) | 31 | 39 | 122 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Patients Treated With MTX) | 19 | 38 | 84 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Arm I (Patients Treated Without Methotrexate (MTX)) | 1 | 39 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Arm II (Patients Treated With MTX) | 0 | 38 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Patients Treated Without Methotrexate (MTX)) | 25 | 39 | 53 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Patients Treated With MTX) | 20 | 38 | 43 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Patients Treated Without Methotrexate (MTX)) | 1 | 39 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Patients Treated With MTX) | 0 | 38 | 0 |
| other | Cardiac arrest | Cardiac disorders | Arm I (Patients Treated Without Methotrexate (MTX)) | 1 | 39 | 1 |
| other | Cardiac arrest | Cardiac disorders | Arm II (Patients Treated With MTX) | 0 | 38 | 0 |
1 to 10 of 278Source ClinicalTrials.gov
See all 278 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Patients Treated Without Methotrexate (MTX)) | 18 | 39 |
| Total, all-cause mortality | Arm II (Patients Treated With MTX) | 15 | 38 |
| Total, other adverse events | Arm I (Patients Treated Without Methotrexate (MTX)) | 39 | 39 |
| Total, other adverse events | Arm II (Patients Treated With MTX) | 36 | 38 |
| Total, serious adverse events | Arm I (Patients Treated Without Methotrexate (MTX)) | 8 | 39 |
| Total, serious adverse events | Arm II (Patients Treated With MTX) | 3 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm I (Patients Treated Without Methotrexate (MTX)) vs Arm II (Patients Treated With MTX): Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism | Trial comparisons |
| Arm I (Patients Treated Without Methotrexate (MTX)) vs Arm II (Patients Treated With MTX): Number of Participants With Chronic Low Somatomedin C | Trial comparisons |
| Arm I (Patients Treated Without Methotrexate (MTX)) vs Arm II (Patients Treated With MTX): Number of Participants With Secondary Malignancies | Trial comparisons |
| Arm I (Patients Treated Without Methotrexate (MTX)) vs Arm II (Patients Treated With MTX): Number of Participants With Chronic Diabetes Insipidus | Trial comparisons |
| Arm I (Patients Treated Without Methotrexate (MTX)) vs Arm II (Patients Treated With MTX): deaths from any cause | Trial comparisons |
| Arm I (Patients Treated Without Methotrexate (MTX)) vs Arm II (Patients Treated With MTX): Number of Participants With Chronic Central Hypothyroidism | Trial comparisons |
| Arm I (Patients Treated Without Methotrexate (MTX)) vs Arm II (Patients Treated With MTX): serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Scan Task | Secondary outcome |
Source ConductCognition
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/NCT00336024
GET https://conductscience.org/api/trials/v1/NCT00336024/results?page=2