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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01185 | Registry Identifier | NCI Clinical Trial Registration Program |
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Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
EXPLORATORY OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease risk (high-risk disease vs average-risk disease).
Patients in both strata undergo peripheral blood stem cell or bone marrow harvest.
Stratum 1 (high-risk group):
Stratum 2 (average-risk group):
Some patients undergo a neuropsychology assessment at baseline, before chemotherapy, and then annually for 5 years.
After completion of study therapy, patients are followed every 3 months until month 30 (2.5 years) after diagnosis and then every 6 months until month 72 (6 years) after diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1 (high-risk group) | Experimental | Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy followed by autologous stem cell transplantation (SCT) and filgrastim (G-CSF) with post-transplantation vincristine. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy |
|
| Stratum 2 (average-risk group) | Experimental | Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | Given subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | 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. | 2 years after tumor cell analysis in 122 participants |
| Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | 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. | 2 years after tumor cell analysis in 122 participants |
| Frequency of Mutations Associated With SHH and WNT Tumors | 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. | within 3.5 years following completion of accrual |
| Measure | Description | Time Frame |
|---|---|---|
| Reading Decoding Composite Scores in the Intervention and Standard of Care Groups | 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). |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Definitive surgery for CNS tumor within the past 31 days
Meets one of the following risk criteria:
Average-risk disease
Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI
T4 disease eligible if all of the following are true:
Brain stem invasion allowed in the absence of residual tumor (tumor < 1.5 cm^2 by imaging)
High-risk disease meeting one of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Amar Gajjar, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States | ||
| Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34714708 | Derived | Acharya S, Guo Y, Patni T, Li Y, Wang C, Gargone M, Ashford JM, Wilson L, Faught A, Reddick WE, Patay Z, Gajjar A, Conklin HM, Merchant TE. Association Between Brain Substructure Dose and Cognitive Outcomes in Children With Medulloblastoma Treated on SJMB03: A Step Toward Substructure-Informed Planning. J Clin Oncol. 2022 Jan 1;40(1):83-95. doi: 10.1200/JCO.21.01480. Epub 2021 Oct 29. | |
| 33743477 |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
Not provided
Of the 416 participants enrolled, three were ineligible and taken off study.
416 participants were enrolled between 9/9/2003 and 3/7/2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Average-Risk Group | Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cisplatin | Drug | Given IV |
|
|
| cyclophosphamide | Drug | Given IV |
|
|
| vincristine | Drug | Given IV |
|
|
| autologous hematopoietic stem cell transplantation | Procedure | Patients undergo autologous stem cell transplantation |
|
|
| radiation therapy | Radiation | Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. |
|
|
| 5 years postdiagnosis |
| Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa | To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation. | Annually for 6 years post irradiation |
| Associative Memory for Two Risk Group 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. | At enrollment |
| Associative Memory for Two Risk Group 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. | At 5 years after enrollment |
| Processing Speed for Two Risk Group 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. | At enrollment |
| Processing Speed for Two Risk Group 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. | At 5 years after enrollment |
| Perceptual Speed for Two Risk Group 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. | At enrollment |
| Perceptual Speed for Two Risk Group at 5 Years After Enrollment | Assessment of Perceptual Speed at 5 years after 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. | At 5 years after enrollment |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston | Texas | 77030-2399 | United States |
| Sydney Children's Hospital | Randwick | New South Wales | 2031 | Australia |
| Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Lady Cilento Children's Hospital, Brisbane | Brisbane | Queensland | 4029 | Australia |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Hospital for Sick Children | Toronto | Ontario | M5S 0A4 | Canada |
| Derived |
| Partanen M, Anghelescu DL, Hall L, Schreiber JE, Rossi M, Gajjar A, Jacola LM. Longitudinal associations between exposure to anesthesia and neurocognitive functioning in pediatric medulloblastoma. Eur J Cancer. 2021 May;148:103-111. doi: 10.1016/j.ejca.2021.02.010. Epub 2021 Mar 17. |
| 33502920 | Derived | Kumar R, Smith KS, Deng M, Terhune C, Robinson GW, Orr BA, Liu APY, Lin T, Billups CA, Chintagumpala M, Bowers DC, Hassall TE, Hansford JR, Khuong-Quang DA, Crawford JR, Bendel AE, Gururangan S, Schroeder K, Bouffet E, Bartels U, Fisher MJ, Cohn R, Partap S, Kellie SJ, McCowage G, Paulino AC, Rutkowski S, Fleischhack G, Dhall G, Klesse LJ, Leary S, Nazarian J, Kool M, Wesseling P, Ryzhova M, Zheludkova O, Golanov AV, McLendon RE, Packer RJ, Dunham C, Hukin J, Fouladi M, Faria CC, Pimentel J, Walter AW, Jabado N, Cho YJ, Perreault S, Croul SE, Zapotocky M, Hawkins C, Tabori U, Taylor MD, Pfister SM, Klimo P Jr, Boop FA, Ellison DW, Merchant TE, Onar-Thomas A, Korshunov A, Jones DTW, Gajjar A, Ramaswamy V, Northcott PA. Clinical Outcomes and Patient-Matched Molecular Composition of Relapsed Medulloblastoma. J Clin Oncol. 2021 Mar 1;39(7):807-821. doi: 10.1200/JCO.20.01359. Epub 2021 Jan 27. |
| 33405951 | Derived | Gajjar A, Robinson GW, Smith KS, Lin T, Merchant TE, Chintagumpala M, Mahajan A, Su J, Bouffet E, Bartels U, Schechter T, Hassall T, Robertson T, Nicholls W, Gururangan S, Schroeder K, Sullivan M, Wheeler G, Hansford JR, Kellie SJ, McCowage G, Cohn R, Fisher MJ, Krasin MJ, Stewart CF, Broniscer A, Buchhalter I, Tatevossian RG, Orr BA, Neale G, Klimo P Jr, Boop F, Srinivasan A, Pfister SM, Gilbertson RJ, Onar-Thomas A, Ellison DW, Northcott PA. Outcomes by Clinical and Molecular Features in Children With Medulloblastoma Treated With Risk-Adapted Therapy: Results of an International Phase III Trial (SJMB03). J Clin Oncol. 2021 Mar 1;39(7):822-835. doi: 10.1200/JCO.20.01372. Epub 2021 Jan 6. |
| 25665007 | Derived | Xu H, Robinson GW, Huang J, Lim JY, Zhang H, Bass JK, Broniscer A, Chintagumpala M, Bartels U, Gururangan S, Hassall T, Fisher M, Cohn R, Yamashita T, Teitz T, Zuo J, Onar-Thomas A, Gajjar A, Stewart CF, Yang JJ. Common variants in ACYP2 influence susceptibility to cisplatin-induced hearing loss. Nat Genet. 2015 Mar;47(3):263-6. doi: 10.1038/ng.3217. Epub 2015 Feb 9. |
| Clinical Trials Open at St. Jude | View source |
| FG001 | High-Risk Group | Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Participants had a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Average-Risk Group | Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2). |
| BG001 | High-Risk Group | Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors | 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. | 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. | Posted | Number | 95% Confidence Interval | probability of PFS at 2 years | 2 years after tumor cell analysis in 122 participants |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | 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. | 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. | Posted | Number | 95% Confidence Interval | probability of PFS at 2 years | 2 years after tumor cell analysis in 122 participants |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Frequency of Mutations Associated With SHH and WNT Tumors | 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. | 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. | Posted | Count of Participants | Participants | No | within 3.5 years following completion of accrual |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Reading Decoding Composite Scores in the Intervention and Standard of Care Groups | 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). | 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. | Posted | Mean | Standard Error | score on a scale | 5 years postdiagnosis |
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| Secondary | Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa | To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation. | 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. | Posted | Count of Participants | Participants | Annually for 6 years post irradiation |
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| Secondary | Associative Memory for Two Risk Group 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. | 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. | Posted | Mean | Standard Error | score on a scale | At enrollment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Associative Memory for Two Risk Group 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. | 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. | Posted | Mean | Standard Error | score on a scale | At 5 years after enrollment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Processing Speed for Two Risk Group 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. | 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. | Posted | Mean | Standard Error | score on a scale | At enrollment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Processing Speed for Two Risk Group 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. | 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. | Posted | Mean | Standard Error | score on a scale | At 5 years after enrollment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Perceptual Speed for Two Risk Group 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. | 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. | Posted | Mean | Standard Error | score on a scale | At enrollment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Perceptual Speed for Two Risk Group at 5 Years After Enrollment | Assessment of Perceptual Speed at 5 years after 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. | 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. | Posted | Mean | Standard Error | score on a scale | At 5 years after enrollment |
|
Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.
Per protocol, Grade 3 and 4 hematologic toxicities, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected if they occurred from the beginning of radiation therapy through the end of 4 courses of high dose chemotherapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Average-Risk Group | Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2). | 17 | 269 | 236 | 269 | ||
| EG001 | High-Risk Group | Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery. | 17 | 144 | 118 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Supraventricular and nodal arrhythmia - sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac general - other | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombotic microangiopathy | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment | e.g., thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS) |
|
| Death not associated with CTCAE term, death NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/bleeding - other | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pancreatitis | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Fever of unknown origin without clinically or microbiologically documented infection (ANC <1.0 x 10e9/L). |
|
| Infection, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L). |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, meninges (meningitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC, meninges (meningitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC, wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Musculoskeletal/soft tissue - other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Apnea | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| CNS necrosis/cystic progression | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Leak, cerebrospinal fluid (CSF) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Leukoencephalopathy (radiographic findings) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Personality/behavioral | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pulmonary fibrosis (radiographic changes) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pulmonary/upper respiratory - other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Syndromes - other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Fever of unknown origin without clinically or microbiologically documented infection (ANC <1.0 x 10e9/L). |
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| Infection, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L). |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain, abdomen NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Infection - other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Infection, catheter-related | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L). |
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| Hemorrhage, pulmonary/upper respiratory, nose | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain, head/headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hearing: patients with/without baseline audiogram and enrolled in a monitoring program | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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.
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amar Gajjar, MD | St. Jude Children's Research Hospital | 866-278-5833 | info@stjude.org |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D018335 | Rhabdoid Tumor |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
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Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
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| Negative ERBB2 |
|
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| 95 |
| Superiority or Other (legacy) |
| Log Rank | 0.7696 | 95 | Superiority or Other (legacy) |
| OG003 | ERBB2 Negative & High Risk | 14 participants who were ERBB2 negative and in the high risk group |
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Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).
| OG004 | SHH Pathway - SNV Somatic | Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV). |
| OG005 | WNT Pathway - SNV Somatic | Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV). |
| OG006 | SHH Pathway - SNV Germline | Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV). |
| OG007 | WNT Pathway - SNV Germline | Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV). |
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| OG001 | Standard of Care | THE CURRENT STANDARD OF CARE ON READING DECODING SKILLS |
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Participants assigned to the high- risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery. |
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