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NCT00392327 · CITED IN SOURCE DOCUMENTS

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-06-08

This phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Chemotherapy drugs, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma

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outcome · POSTED

Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)

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outcome · POSTED

Tumor Response to Radiation Therapy for Patients With Medulloblastoma

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outcome · POSTED

Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)

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outcome · POSTED

Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma

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outcome · POSTED

Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)

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outcome · POSTED

The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients

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outcome · NOT POSTED

The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients

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outcome · NOT POSTED

The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for Medulloblastoma Patients

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outcome · POSTED

The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients

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outcome · POSTED

The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for SPNET Patients

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outcome · POSTED

The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for SPNET Patients

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outcome · POSTED

Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients

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outcome · NOT POSTED

Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients

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outcome · NOT POSTED

Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for Medulloblastoma Patients

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outcome · POSTED

Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for SPNET Patients

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outcome · POSTED

Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for SPNET Patients

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outcome · POSTED

Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Age greater than or equal to 3 and less than 22 years at the time of diagnosis * Newly diagnosed, previously untreated: (1) M0 medulloblastoma with \> 1.5 cm\^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor * As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued * All patients with M4 disease are not eligible * A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility since radiation therapy planning and response will be based on MRI scans only * Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory * Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred because surgically-induced inflammation/blood can be difficult to distinguish from tumor * Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained \> 7 days post-operatively (to rule out surgically induced false positives) * Patients must have a Karnofsky performance level of \>= 30 for patients \> 16 years of age or a Lansky performance scale of \>= 30 for patients =\< 16 years of age and life expectancy \> 8 weeks * No previous chemotherapy or radiation therapy * Corticosteroids should not be used during chemotherapy administration as an antiemetic because of their effect on the blood-brain barrier * Clinically significant drug interactions have been reported when using vincristine with strong CYP450 3A4 inhibitors and inducers. Selected strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (cytochrome P450 3A4) include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort; the use of these drugs should be avoided with vincristine (vincristine sulfate) * The clinical outcome and significance of CYP450 interactions with cyclophosphamide are less clear. CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution; aprepitant also interacts with CYP3A4 and should be used with caution with etoposide or vincristine chemotherapy * Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity * In patients receiving cisplatin and phenytoin or fosphenytoin, serum concentrations of phenytoin may decrease. Carbamazepine concentration may also decrease with concomitant use. Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin * No other experimental therapy is permitted while on study * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/gender as follows: * 0.8 mg/dL (2 to \< 6 years of age) * 1.0 mg/dL (6 to \< 10 years of age) * 1.2 mg/dL (10 to \< 13 years of age) * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age) * 1.7 mg/dL (male) or 1.4 mg/dL (female) (\>= 16 years of age) * Total bilirubin \< 1.5 x upper limit of normal (ULN) for age * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age; for patients on anti-seizure medications, SGOT (AST) or SGPT (ALT) must be \< 5 x ULN * Absolute neutrophil count (ANC) \>= 1,000/uL * Platelets \>= 100,000/uL (untransfused) * Hemoglobin \>= 8 g/dl (may be transfused) * There is information indicating a risk of fetal or teratogenic toxicity with this treatment. Female patients who are post-menarchal must have a negative pregnancy test; lactating female patients must agree not to breast-feed while on this trial; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
healthy Volunteers
false
maximum Age
22 Years
minimum Age
3 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    CHEMORADIOTHERAPY: Patients undergo radiation therapy QD five days a week for 6 weeks. Patients also receive vincristine sulfate IV over 1 minute once weekly for 6 weeks. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim SC or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, lumbar puncture and MRI throughout the study.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Drug: Cisplatin
    3. Drug: Cyclophosphamide
    4. Biological: Filgrastim
    5. Procedure: Lumbar Puncture
    6. Procedure: Magnetic Resonance Imaging
    7. Other: Quality-of-Life Assessment
    8. Radiation: Radiation Therapy
    9. Drug: Vincristine Sulfate
    label
    Arm A (chemoradiotherapy)
    type
    ACTIVE_COMPARATOR
  2. description
    CHEMORADIOTHERAPY: Patients receive vincristine sulfate and undergo radiation therapy as in Arm A. Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm A. Patients also undergo blood sample collection, lumbar puncture and MRI throughout the study.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Drug: Carboplatin
    3. Drug: Cisplatin
    4. Drug: Cyclophosphamide
    5. Biological: Filgrastim
    6. Procedure: Lumbar Puncture
    7. Procedure: Magnetic Resonance Imaging
    8. Other: Quality-of-Life Assessment
    9. Radiation: Radiation Therapy
    10. Drug: Vincristine Sulfate
    label
    Arm B (chemoradiotherapy)
    type
    EXPERIMENTAL
  3. description
    CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm A. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive isotretinoin PO BID on day 1 and days 16-28 and cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim as in Arm A maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy. CONTINUATION THERAPY: Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Cisplatin
    2. Drug: Cyclophosphamide
    3. Biological: Filgrastim
    4. Drug: Isotretinoin
    5. Other: Quality-of-Life Assessment
    6. Radiation: Radiation Therapy
    7. Drug: Vincristine Sulfate
    label
    Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    type
    EXPERIMENTAL
  4. description
    CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm B. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm C. Patients then proceed to continuation therapy. CONTINUATION THERAPY: Patients receive continuation therapy as in Arm C.
    intervention Names
    1. Drug: Carboplatin
    2. Drug: Cisplatin
    3. Drug: Cyclophosphamide
    4. Biological: Filgrastim
    5. Drug: Isotretinoin
    6. Other: Quality-of-Life Assessment
    7. Radiation: Radiation Therapy
    8. Drug: Vincristine Sulfate
    label
    Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    description
    Undergo blood sample collection
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Sample Collection
    4. Specimen Collection
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm B (chemoradiotherapy)
    2. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Given IV
    name
    Carboplatin
    other Names
    1. Blastocarb
    2. Carboplat
    3. Carboplatin Hexal
    4. Carboplatino
    5. Carboplatinum
    6. Carbosin
    7. Carbosol
    8. Carbotec
    9. CBDCA
    10. Displata
    11. Ercar
    12. JM-8
    type
    DRUG
  3. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    3. Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    4. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  4. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    3. Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    4. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Given IV
    name
    Cyclophosphamide
    other Names
    1. (-)-Cyclophosphamide
    2. 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    3. Asta B 518
    4. B 518
    5. B-518
    6. B518
    7. Carloxan
    8. Ciclofosfamida
    9. Ciclofosfamide
    10. Cicloxal
    11. Clafen
    12. Claphene
    type
    DRUG
  5. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    3. Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    4. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Given IV or SC
    name
    Filgrastim
    other Names
    1. Filgrastim Biosimilar Filgrastim-sndz
    2. Filgrastim Biosimilar Tbo-filgrastim
    3. Filgrastim XM02
    4. Filgrastim-aafi
    5. Filgrastim-ayow
    6. Filgrastim-sndz
    7. G-CSF
    8. Granix
    9. Neupogen
    10. Neutroval
    11. Nivestim
    12. Nivestym
    type
    BIOLOGICAL
  6. arm Group Labels
    1. Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    2. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Given PO
    name
    Isotretinoin
    other Names
    1. 13-cis retinoic acid
    2. 13-cis-Retinoate
    3. 13-cis-Retinoic Acid
    4. 13-cis-Vitamin A Acid
    5. 13-cRA
    6. Absorica
    7. Accure
    8. Accutane
    9. Amnesteem
    10. cis-Retinoic Acid
    11. Cistane
    12. Claravis
    type
    DRUG
  7. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    description
    Undergo lumbar puncture
    name
    Lumbar Puncture
    other Names
    1. LP
    2. Spinal Tap
    type
    PROCEDURE
  8. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    description
    Undergo MRI
    name
    Magnetic Resonance Imaging
    other Names
    1. Magnetic Resonance
    2. Magnetic Resonance Imaging (MRI)
    3. Magnetic resonance imaging (procedure)
    4. Magnetic Resonance Imaging Scan
    5. Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    6. MR
    7. MR Imaging
    8. MRI
    9. MRI Scan
    10. MRIs
    11. NMR Imaging
    12. NMRI
    type
    PROCEDURE
  9. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    3. Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    4. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  10. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    3. Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    4. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Undergo radiation therapy
    name
    Radiation Therapy
    other Names
    1. Cancer Radiotherapy
    2. Energy Type
    3. ENERGY_TYPE
    4. Irradiate
    5. Irradiated
    6. Irradiation
    7. Radiation
    8. Radiation Therapy, NOS
    9. Radiotherapeutics
    10. Radiotherapy
    11. RT
    12. Therapy, Radiation
    type
    RADIATION
  11. arm Group Labels
    1. Arm A (chemoradiotherapy)
    2. Arm B (chemoradiotherapy)
    3. Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    4. Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)
    description
    Given IV
    name
    Vincristine Sulfate
    other Names
    1. Kyocristine
    2. Leurocristine Sulfate
    3. Leurocristine, sulfate
    4. Oncovin
    5. Vincasar
    6. Vincosid
    7. Vincrex
    8. Vincristine, sulfate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
379
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma
    time Frame
    Up to 5 years
  2. description
    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.
    measure
    Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
    time Frame
    Up to 5 years
secondary Outcomes
  1. description
    Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses.
    measure
    Tumor Response to Radiation Therapy for Patients With Medulloblastoma
    time Frame
    12 weeks after treatment initiation
  2. description
    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.
    measure
    Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
    time Frame
    12 weeks after treatment initiation
  3. description
    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.
    measure
    Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma
    time Frame
    Up to 5 years
  4. description
    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.
    measure
    Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
    time Frame
    Up to 5 years
  5. description
    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.
    measure
    The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
    time Frame
    6 - 12 months post diagnosis
  6. description
    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.
    measure
    The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients
    time Frame
    24 - 36 months post diagnosis
  7. description
    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.
    measure
    The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for Medulloblastoma Patients
    time Frame
    48 - 72 months post diagnosis
  8. description
    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.
    measure
    The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients
    time Frame
    6 - 12 months post diagnosis
  9. description
    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.
    measure
    The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for SPNET Patients
    time Frame
    24 - 36 months post diagnosis
  10. description
    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.
    measure
    The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for SPNET Patients
    time Frame
    48 - 72 months post diagnosis
  11. description
    Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported.
    measure
    Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
    time Frame
    6 - 12 months post diagnosis
  12. description
    Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. SPNET is no longer recognized by WHO (World Health Organization) as a disease entity. Additional trial information can be found under PubMed® # 30332335.
    measure
    Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients
    time Frame
    24 - 36 months post diagnosis
Full study description
brief Summary
This phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Chemotherapy drugs, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
detailed Description
PRIMARY OBJECTIVES: I. To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastoma/primitive neuroectodermal tumor (PNET) patients. II. To determine whether isotretinoin increases long term event-free survival for high risk medulloblastoma/PNET patients. CORRELATIVE SCIENCE OBJECTIVES: I. To compare residual disease response to radiation alone versus radiation plus carboplatin. II. To identify molecular prognostic indicators suitable for patient stratification in future trials. III. To evaluate the health-related quality of life (HRQOL) during phases of active treatment specific to treatment modalities. IV. To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life. OUTLINE: Patients are randomized to Arm A or Arm B (Arms C and D closed to accrual as of Amendment 3 1/27/15). ARM A (standard chemoradiotherapy and standard maintenance therapy): CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily (QD) five days a week for 6 weeks. Patients also receive vincristine sulfate intravenously (IV) over 1 minute once weekly for 6 weeks. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim subcutaneously (SC) or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, lumbar puncture and magnetic resonance imaging (MRI) throughout the study. ARM B (standard chemoradiotherapy plus carboplatin and standard maintenance therapy): CHEMORADIOTHERAPY: Patients receive vincristine sulfate and undergo radiation therapy as in Arm I. Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm I. Patients also undergo blood sample collection, lumbar puncture and MRI throughout the study. ARM C (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 1/27/15): CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive isotretinoin orally (PO) twice daily (BID) on day 1 and days 16-28 and cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim as in Arm I maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy. CONTINUATION THERAPY: Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM D (standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 1/27/15): CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm II. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm III. Patients then proceed to continuation therapy. CONTINUATION THERAPY: Patients receive continuation therapy as in Arm III. After completion of study treatment, patients are followed up periodically for 1 year.
Source references
references
  1. citation
    Hwang EI, Kool M, Burger PC, Capper D, Chavez L, Brabetz S, Williams-Hughes C, Billups C, Heier L, Jaju A, Michalski J, Li Y, Leary S, Zhou T, von Deimling A, Jones DTW, Fouladi M, Pollack IF, Gajjar A, Packer RJ, Pfister SM, Olson JM. Extensive Molecular and Clinical Heterogeneity in Patients With Histologically Diagnosed CNS-PNET Treated as a Single Entity: A Report From the Children's Oncology Group Randomized ACNS0332 Trial. J Clin Oncol. 2018 Oct 17;36(34):JCO2017764720. doi: 10.1200/JCO.2017.76.4720. Online ahead of print.
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  2. citation
    Leary SES, Packer RJ, Li Y, Billups CA, Smith KS, Jaju A, Heier L, Burger P, Walsh K, Han Y, Embry L, Hadley J, Kumar R, Michalski J, Hwang E, Gajjar A, Pollack IF, Fouladi M, Northcott PA, Olson JM. Efficacy of Carboplatin and Isotretinoin in Children With High-risk Medulloblastoma: A Randomized Clinical Trial From the Children's Oncology Group. JAMA Oncol. 2021 Sep 1;7(9):1313-1321. doi: 10.1001/jamaoncol.2021.2224.
    pmid
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    type
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        </a>]</p> <p id="_1832" tabindex="-1">An accurate diagnosis is critical for patients with embryonal tumors. For example, in the <a href="/clinicaltrials/NCT00392327">ACNS0332 (NCT00392327)</a> trial that enrolled 80 patients with high-risk medulloblastoma, supratentorial CNS-PNET tumors, and pineoblastoma, 60 patients had
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        _1832" tabindex="-1">An accurate diagnosis is critical for patients with embryonal tumors. For example, in the <a href="/clinicaltrials/NCT00392327">ACNS0332 (NCT00392327)</a> trial that enrolled 80 patients with high-risk medulloblastoma, supratentorial CNS-PNET tumors, and pineoblastoma, 60 patients had sufficient tissue for e
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        tin, has also been used and has resulted in 5-year PFS rates of approximately 60%.[<a href="#cit/section_2.58">58</a>]</li><li>The COG <a href="/clinicaltrials/NCT00392327">ACNS0332 (NCT00392327)</a> study randomly assigned patients to receive daily carboplatin compared with weekly vincristine during radiation therapy (36 Gy cran
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        and has resulted in 5-year PFS rates of approximately 60%.[<a href="#cit/section_2.58">58</a>]</li><li>The COG <a href="/clinicaltrials/NCT00392327">ACNS0332 (NCT00392327)</a> study randomly assigned patients to receive daily carboplatin compared with weekly vincristine during radiation therapy (36 Gy craniospinal plus a posteri
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        id','CDR0000810033&amp;version=HealthProfessional&amp;language=English'); return(false);">Level of evidence B4</a>] A published study (<a href="/clinicaltrials/NCT00392327">COG-ACNS0332 [NCT00392327]</a>) of molecularly classified nonmedulloblastoma embryonal tumors revealed improved overall survival (OS) for patients who had les
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        ion=HealthProfessional&amp;language=English'); return(false);">Level of evidence B4</a>] A published study (<a href="/clinicaltrials/NCT00392327">COG-ACNS0332 [NCT00392327]</a>) of molecularly classified nonmedulloblastoma embryonal tumors revealed improved overall survival (OS) for patients who had less than 1.5 cm<span class="s
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        7&amp;version=HealthProfessional&amp;language=English'); return(false);">Level of evidence A1</a>] The Children's Oncology Group (COG) <a href="/clinicaltrials/NCT00392327">COG-ACNS0332 (NCT00392327)</a> study of 36 patients with nonmedulloblastoma embryonal tumors (which included 26 pineoblastomas) reported a 5-year overall surv
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        ional&amp;language=English'); return(false);">Level of evidence A1</a>] The Children's Oncology Group (COG) <a href="/clinicaltrials/NCT00392327">COG-ACNS0332 (NCT00392327)</a> study of 36 patients with nonmedulloblastoma embryonal tumors (which included 26 pineoblastomas) reported a 5-year overall survival (OS) rate of 78.5% (95
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        the time of diagnosis, survival is considerably poorer.[<a href="#cit/section_4.13">13</a>,<a href="#cit/section_4.14">14</a>] In the <a href="/clinicaltrials/NCT00392327">COG-ACNS0332 (NCT00392327)</a> study, there was no significant difference in event-free survival or OS according to metastatic status.</p> </section>
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        vival is considerably poorer.[<a href="#cit/section_4.13">13</a>,<a href="#cit/section_4.14">14</a>] In the <a href="/clinicaltrials/NCT00392327">COG-ACNS0332 (NCT00392327)</a> study, there was no significant difference in event-free survival or OS according to metastatic status.</p> </section> </section> <sec
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        Updated: April 11, 2025
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        April 11, 2025

    Preserved source evidence · Not medical advice