CNS Neoplasm (Primary Tumor) - Embryonal Tumors

NCT00085735

Clinical Trial Information


Trial Number: NCT00085735 (ClinicalTrials.gov)
Disease Type:
  • CNS Neoplasm (Primary Tumor) - Embryonal Tumors
Trial Title:
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
Study ID:
ACNS0331
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00085735-D1 There is one data submission associated with PMID 34110925: NCT00085735-D1. This dataset provides the information for baseline characteristics, primary analyses, adverse events, molecular analyses, and QOL analyses reported in the manuscript, figures, and tables. There is one row per patient.

NCT00653068

Clinical Trial Information


Trial Number: NCT00653068 (ClinicalTrials.gov)
Disease Type:
  • CNS Neoplasm (Primary Tumor) - Embryonal Tumors
Trial Title:
Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System with Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation
Study ID:
ACNS0333
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00653068-D3 There are 3 data submissions (NCT00653068-D1, -D2, and -D3) associated with PMID 32105509. This dataset, NCT00653068-D3, provides specific data for the outcome, event-free survival (EFS), of Figure 3B, the primary analytic comparison: ACNS0333 patients < 36 months of age verses the historical control.
NCT00653068-D2 There are 3 data submissions (NCT00653068-D1, -D2, and -D3) associated with PMID 32105509. This dataset, NCT00653068-D2, provides specific incidence of grade 4 or higher adverse events that occurred in 5% or more of patients in at least one phase of therapy. This dataset is necessary to construct Table A2 (Treatment-Associated Toxicity).
NCT00653068-D1 There are 3 data submissions (NCT00653068-D1, -D2, and -D3) associated with PMID 32105509. This dataset, NCT00653068-D1, provides information on the flow of patients enrolled in ACNS0333 through therapy shown in the CONSORT diagram in Figure 2, the variable categories of Table 3 and Table 4, and other variables to define patient attributes and outcomes as reported in the manuscript. There is one row for each patient enrolled.

NCT00392327

Clinical Trial Information


Trial Number: NCT00392327 (ClinicalTrials.gov)
Disease Type:
  • CNS Neoplasm (Primary Tumor) - Embryonal Tumors
Trial Title:
Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
Study ID:
ACNS0332
Images are available?:
Yes
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00392327-D4 NCT00392327-D4 is the only data submission associated with PMID 34292305, which is the publication describing the high-risk cohort in ACNS0332. This dataset provides the information for baseline characteristics, primary analyses reported in the manuscript, figures, and tables. There is one row per patient.
NCT00392327-D3 As of November 2019, there is only one dataset associated with this publication (PMID 31601576). This dataset contains patient characteristics (age and sex), magnetic resonance imaging (MRI) features, methylation profiling results, and event-free survival data for patients with institutionally diagnosed supratentorial primitive neuroectodermal tumors of the CNS (CNS-PNETs) and pineoblastomas (PBLs) who were enrolled on ACNS0332 and had molecular classification by DNA methylation and imaging data. Of the 85 patients with institutionally diagnosed CNS-PNET/pineoblastoma enrolled and randomized on ACNS0332, 56 met the inclusion criteria for this manuscript.

The data from the ACNS0332 primary publication (PMID 30332335) can be found in NCT00392327-D1 and -D2.
NCT00392327-D2 NCT00392327-D2-Dataset
The second dataset (D2) contains data provided by the central pathologist on the 10 patients who were selected for a second central pathology review, given the discrepancies between profiling and centrally reviewed histopathologic diagnoses. This second central pathology review was done at the request of one of the journal article reviewers. The text in the results section of the manuscript and the associated data are geared towards pathologists rather than the general readership.
NCT00392327-D1 NCT00392327-D1-Dataset
As of June 2019, there are two datasets associated with this publication (PMID 30332335). The first dataset (D1) contains patient characteristics, toxicity, methylation profiling results and primary outcome analyses for the subset of patients with institutionally diagnosed supratentorial primitive neuroectodermal tumors of the CNS (CNS-PNETs) and pineoblastomas (PBLs) who were enrolled on ACNS0332 as reported in the manuscript (n=85).

NCT00716976

Clinical Trial Information


Trial Number: NCT00716976 (ClinicalTrials.gov)
Disease Type:
  • Bone Neoplasm - Osteosarcoma
  • CNS Neoplasm (Primary Tumor) - Embryonal Tumors
  • CNS-excluded Nervous System Neoplasm and Disorder - Neuroblastoma
  • Gastrointestinal Neoplasm - Liver and Hepatobiliary Cancer
  • Germ Cell Neoplasm - Miscellaneous
  • Miscellaneous Neoplasm - Solid Tumor
Trial Title:
A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
Study ID:
ACCL0431
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00716976-D3 NCT00716976-D3
One row for each of the 194 serious adverse events detailed on manuscript page 69. These events are reported through the National Cancer Institute, Cancer Therapy Evaluation Program, Adverse Event Reporting System (CTEP-AERS).
NCT00716976-D2 NCT00716976-D2
These data provide the incidence of toxicities. There is one record per patient-cycle. analysiset2=1 for rows included in Table 3 construction. analysiset3=1 for rows included in Table 4 construction.
NCT00716976-D1 NCT00716976-D1
There is one row for each patient enrolled. The first 14 variables are used to make Figure 1. Patients considered for analysis of study outcomes have the variable analysiset1=1. Variables 15-50 provide patient characteristics (Table 1), outcome (Figures 2 and 3) and hearing loss comparisons (Table 2).