Skip to content
Triangle logo TriangleGet started
← Study library

NCT00085735 · CITED IN SOURCE DOCUMENTS

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

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
2026-06-09

This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Event-free Survival (EFS)

→

outcome · POSTED

Overall Survival (OS)

→

outcome · POSTED

Local Posterior Fossa (LPF) Failure Rate

→

outcome · POSTED

Non-local Posterior Fossa (NLPF) Failure Rate

→

outcome · POSTED

Non-posterior Fossa (NPF) Failure Rate

→

outcome · POSTED

Post-treatment Endocrine Function by CSI Group

→

outcome · POSTED

Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4

→

outcome · POSTED

Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).

→

outcome · POSTED

Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)

→

outcome · POSTED

Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)

→

outcome · POSTED

Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4

→

outcome · POSTED

Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group

→

outcome · POSTED

Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays

→

outcome · POSTED

Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays

→

outcome · POSTED

Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)

→

outcome · POSTED

Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)

→

outcome · POSTED

Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)

→

outcome · POSTED

Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)

→

outcome · POSTED

Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)

→

outcome · POSTED

Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed medulloblastoma located in the posterior fossa * Standard-risk disease * Minimal volume, non-disseminated disease, defined by the following: * Residual tumor ≤ 1.5 cm\^2 confirmed by MRI with contrast imaging within 21 days after surgery * No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following: * Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery * Negative cytological examination of CSF after surgery, but before study enrollment * Brain stem involvement allowed * Performance status - Karnofsky 50-100% (\> 16 years of age) * Performance status - Lansky 30-100% (≤ 16 years of age) * Absolute neutrophil count \> 1,500/uL * Platelet count \> 100,000/uL (transfusion independent) * Hemoglobin \> 10 g/dL (transfusions allowed) * Bilirubin \< 1.5 times upper limit of normal (ULN) for age * AST or ALT \< 1.5 times ULN for age * Creatinine clearance OR radioisotope glomerular filtration rate \>= 70 mL/min/1.73m\^2 or a serum creatinine based on age/gender as follows: Age Maximum Serum Creatine (mg/dL) * 1month to \< 6 months male: 0.4 female: 0.4 * 6 months to \<1 year male: 0.5 female: 0.5 * 1 year to \< 2 years male: 0.6 female: 0.6 * 2 to \< 6 years male: 0.8 female: 0.8 * 6 to \< 10 years male: 1 female: 1 * 10 to \< 13 years male: 1.2 female: 1.2 * 13 to \< 16 years male: 1.5 female: 1.4 * \>= 16 years male: 1.7 female: 1.4 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior chemotherapy * Prior corticosteroids allowed * No prior radiotherapy
healthy Volunteers
false
maximum Age
21 Years
minimum Age
3 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    See Detailed Description (Arm I)
    intervention Names
    1. Drug: Cisplatin
    2. Radiation: Craniospinal Irradiation
    3. Drug: Cyclophosphamide
    4. Radiation: Involved-Field Radiation Therapy
    5. Other: Laboratory Biomarker Analysis
    6. Drug: Lomustine
    7. Other: Quality-of-Life Assessment
    8. Drug: Vincristine Sulfate
    label
    Arm I (3-7 years of age, LDCSI, IFRT)
    type
    EXPERIMENTAL
  2. description
    See Detailed Description (Arm II)
    intervention Names
    1. Drug: Cisplatin
    2. Radiation: Craniospinal Irradiation
    3. Drug: Cyclophosphamide
    4. Other: Laboratory Biomarker Analysis
    5. Drug: Lomustine
    6. Other: Quality-of-Life Assessment
    7. Radiation: Radiation Therapy
    8. Drug: Vincristine Sulfate
    label
    Arm II (3-7 years of age, LDCSI, PFRT)
    type
    EXPERIMENTAL
  3. description
    See Detailed Description (Arm III)
    intervention Names
    1. Drug: Cisplatin
    2. Radiation: Craniospinal Irradiation
    3. Drug: Cyclophosphamide
    4. Radiation: Involved-Field Radiation Therapy
    5. Other: Laboratory Biomarker Analysis
    6. Drug: Lomustine
    7. Other: Quality-of-Life Assessment
    8. Drug: Vincristine Sulfate
    label
    Arm III (3-7 years of age, SDCSI, IFRT)
    type
    EXPERIMENTAL
  4. description
    See Detailed Description (Arm IV)
    intervention Names
    1. Radiation: Craniospinal Irradiation
    2. Drug: Cyclophosphamide
    3. Other: Laboratory Biomarker Analysis
    4. Drug: Lomustine
    5. Other: Quality-of-Life Assessment
    6. Radiation: Radiation Therapy
    7. Drug: Vincristine Sulfate
    label
    Arm IV (3-7 years of age, SDCSI, PFRT)
    type
    ACTIVE_COMPARATOR
  5. description
    See Detailed Description (Arm V)
    intervention Names
    1. Drug: Cisplatin
    2. Radiation: Craniospinal Irradiation
    3. Drug: Cyclophosphamide
    4. Radiation: Involved-Field Radiation Therapy
    5. Other: Laboratory Biomarker Analysis
    6. Drug: Lomustine
    7. Other: Quality-of-Life Assessment
    8. Drug: Vincristine Sulfate
    label
    Arm V (8-21 years of age, SDCSI, IFRT)
    type
    EXPERIMENTAL
  6. description
    See Detailed Description (Arm VI)
    intervention Names
    1. Drug: Cisplatin
    2. Radiation: Craniospinal Irradiation
    3. Drug: Cyclophosphamide
    4. Other: Laboratory Biomarker Analysis
    5. Drug: Lomustine
    6. Other: Quality-of-Life Assessment
    7. Radiation: Radiation Therapy
    8. Drug: Vincristine Sulfate
    label
    Arm VI (8-21 years of age, SDCSI, PFRT)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm II (3-7 years of age, LDCSI, PFRT)
    3. Arm III (3-7 years of age, SDCSI, IFRT)
    4. Arm V (8-21 years of age, SDCSI, IFRT)
    5. Arm VI (8-21 years of age, SDCSI, PFRT)
    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
  2. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm II (3-7 years of age, LDCSI, PFRT)
    3. Arm III (3-7 years of age, SDCSI, IFRT)
    4. Arm IV (3-7 years of age, SDCSI, PFRT)
    5. Arm V (8-21 years of age, SDCSI, IFRT)
    6. Arm VI (8-21 years of age, SDCSI, PFRT)
    description
    Undergo craniospinal Irradiation
    name
    Craniospinal Irradiation
    type
    RADIATION
  3. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm II (3-7 years of age, LDCSI, PFRT)
    3. Arm III (3-7 years of age, SDCSI, IFRT)
    4. Arm IV (3-7 years of age, SDCSI, PFRT)
    5. Arm V (8-21 years of age, SDCSI, IFRT)
    6. Arm VI (8-21 years of age, SDCSI, PFRT)
    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
  4. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm III (3-7 years of age, SDCSI, IFRT)
    3. Arm V (8-21 years of age, SDCSI, IFRT)
    description
    Undergo smaller volume boost (involved-field radiation therapy)
    name
    Involved-Field Radiation Therapy
    other Names
    1. IFRT
    2. Involved field radiotherapy
    type
    RADIATION
  5. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm II (3-7 years of age, LDCSI, PFRT)
    3. Arm III (3-7 years of age, SDCSI, IFRT)
    4. Arm IV (3-7 years of age, SDCSI, PFRT)
    5. Arm V (8-21 years of age, SDCSI, IFRT)
    6. Arm VI (8-21 years of age, SDCSI, PFRT)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  6. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm II (3-7 years of age, LDCSI, PFRT)
    3. Arm III (3-7 years of age, SDCSI, IFRT)
    4. Arm IV (3-7 years of age, SDCSI, PFRT)
    5. Arm V (8-21 years of age, SDCSI, IFRT)
    6. Arm VI (8-21 years of age, SDCSI, PFRT)
    description
    Given orally
    name
    Lomustine
    other Names
    1. 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
    2. 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
    3. Belustin
    4. Belustine
    5. CCNU
    6. Cecenu
    7. CeeNU
    8. Chloroethylcyclohexylnitrosourea
    9. Citostal
    10. Gleostine
    11. Lomeblastin
    12. Lomustinum
    type
    DRUG
  7. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm II (3-7 years of age, LDCSI, PFRT)
    3. Arm III (3-7 years of age, SDCSI, IFRT)
    4. Arm IV (3-7 years of age, SDCSI, PFRT)
    5. Arm V (8-21 years of age, SDCSI, IFRT)
    6. Arm VI (8-21 years of age, SDCSI, PFRT)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  8. arm Group Labels
    1. Arm II (3-7 years of age, LDCSI, PFRT)
    2. Arm IV (3-7 years of age, SDCSI, PFRT)
    3. Arm VI (8-21 years of age, SDCSI, PFRT)
    description
    Undergo standard volume boost (whole posterior fossa 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
  9. arm Group Labels
    1. Arm I (3-7 years of age, LDCSI, IFRT)
    2. Arm II (3-7 years of age, LDCSI, PFRT)
    3. Arm III (3-7 years of age, SDCSI, IFRT)
    4. Arm IV (3-7 years of age, SDCSI, PFRT)
    5. Arm V (8-21 years of age, SDCSI, IFRT)
    6. Arm VI (8-21 years of age, SDCSI, PFRT)
    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
549
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).
    measure
    Event-free Survival (EFS)
    time Frame
    Assessed at 3 years
  2. description
    OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy \[IFRT\]) are combined and compared to arms II, IV and VI (posterior fossa irradiation \[PFRT\]).
    measure
    Overall Survival (OS)
    time Frame
    3 years
secondary Outcomes
  1. description
    LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.
    measure
    Local Posterior Fossa (LPF) Failure Rate
    time Frame
    3 years
  2. description
    NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.
    measure
    Non-local Posterior Fossa (NLPF) Failure Rate
    time Frame
    3 years
  3. description
    NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.
    measure
    Non-posterior Fossa (NPF) Failure Rate
    time Frame
    3 years
  4. description
    Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported.
    measure
    Post-treatment Endocrine Function by CSI Group
    time Frame
    Up to 3 years
  5. description
    Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.
    measure
    Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
    time Frame
    Up to 3 years
  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 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.
    measure
    Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).
    time Frame
    4 -15 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 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better.
    measure
    Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)
    time Frame
    27 - 48 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 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.
    measure
    Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
    time Frame
    49 - 72 months post diagnosis
  9. description
    Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.
    measure
    Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
    time Frame
    Up to 3 years
  10. description
    Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests.
    measure
    Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group
    time Frame
    Post-treatment up to 3 years
  11. description
    OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.
    measure
    Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays
    time Frame
    3 years
  12. description
    PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.
    measure
    Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays
    time Frame
    3 years
Full study description
brief Summary
This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.
detailed Description
PRIMARY OBJECTIVE: I. To determine whether reducing the craniospinal dose of radiation therapy to 18.00 Gy in children 3-7 years of age does not compromise event-free survival and overall survival as compared to treatment with 23.40 Gy of craniospinal radiation; and to determine if reducing the irradiated volume of the primary site tumor boost from the whole posterior fossa to the tumor bed only will not compromise event-free and overall survival. SECONDARY OBJECTIVES: I. To evaluate patterns of failure in children treated with an irradiation boost volume smaller than conventional posterior fossa volumes. II. To reduce the cognitive, auditory and endocrinologic effects of treatment of average-risk medulloblastoma by reducing the dose of craniospinal irradiation therapy. III. To determine if the audiologic and endocrinologic toxicity will be reduced with the use of limited tumor boost volume irradiation compared to patients treated with conventional target volumes of radiation. IV. To develop an optimal gene expression medulloblastoma outcome predictor, validated prospectively in a multi-institution randomized clinical trial. V. To improve compliance with long-term quality of life and functional status data submission by educating institutional nurses to administer and submit for analysis a battery of four instruments: Behavior Assessment System for Children- 2nd Edition (BASC-2), Adaptive Behavior Assessment System - 2nd Edition (ABAS-II), Behavior Rating Inventory of Executive Function (BRIEF), PedsQLTM 4.0. OUTLINE: Patients 3-7 years of age are randomized to 1 of 4 arms (Arm I-IV). Patients 8-21 years of age are randomized to 1 of 2 arms (Arm V or VI). Within 31 days after definitive surgery, all patients begin therapy. Patients undergo radiation therapy with doses according to their Arm randomization on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). All patients receive vincristine intravenously (IV) over 1 minute (or infusion via minibag as per institutional policy) on days 8, 15, 22, 29, 36, and 43 (weeks 1-6). ARM I: Patients 3-7 years of age undergo lowered dose craniospinal irradiation (LDCSI) with involved-field radiation therapy (IFRT) boost. ARM II: Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy (PFRT) boost. ARM III: Patients 3-7 years of age undergo standard dose craniospinal irradiation (SDCSI) with IFRT boost. ARM IV: Patients 3-7 years of age undergo SDCSI with PFRT boost. ARM V: Patients 8-21 years of age undergo SDCSI with IFRT boost. ARM VI: Patients 8-21 years of age undergo SDCSI with PFRT boost. MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration. REGIMEN A (courses 1, 2, 4, 5, 7, and 8): Patients receive lomustine orally and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49. REGIMEN B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. OUTLINE: Patients 3-7 years of age are randomized to 1 of 4 arms (Arm I-IV). Patients 8-21 years of age are randomized to 1 of 2 arms (Arm V or VI). Within 31 days after definitive surgery, all patients begin therapy. Patients undergo radiation therapy with doses according to their Arm randomization on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). All patients receive vincristine intravenously (IV) over 1 minute (or infusion via minibag as per institutional policy) on days 8, 15, 22, 29, 36, and 43 (weeks 1-6). ARM I: Patients 3-7 years of age undergo lowered dose craniospinal irradiation (LDCSI) with involved-field radiation therapy (IFRT) boost. ARM II: Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy (PFRT) boost. ARM III: Patients 3-7 years of age undergo standard dose craniospinal irradiation (SDCSI) with IFRT boost. ARM IV: Patients 3-7 years of age undergo SDCSI with PFRT boost. ARM V: Patients 8-21 years of age undergo SDCSI with IFRT boost. ARM VI: Patients 8-21 years of age undergo SDCSI with PFRT boost. MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration. REGIMEN A (courses 1, 2, 4, 5, 7, and 8): Patients receive lomustine orally and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49. REGIMEN B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Source references
avail Ipds
  1. comment
    Data Available: Individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
    type
    Individual Participant Data Set
references
  1. citation
    Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy KK, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, Booth TN, Cherlow JM, Muraszko KM, Hadley J, Kumar R, Han Y, Tarbell NJ, Fouladi M, Pollack IF, Packer RJ, Li Y, Gajjar A, Northcott PA. Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma. J Clin Oncol. 2021 Aug 20;39(24):2685-2697. doi: 10.1200/JCO.20.02730. Epub 2021 Jun 10.
    pmid
    34110925
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-31029d85b571ad70ef48
      requested nct id
      NCT00085735
      primary nct id
      NCT00085735
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      de913ab66946021d86e1a340fa661ff24113f3971f951da28d63bf80bb39bcab
      payload sha256
      b6936fb165cd6f7773f3a428d84d886245e5d11be639eb8f990d3056bb918eec
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-31029d85b571ad70ef48
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00085735
      occurrences
      1. context exact
        or fossa and to the tumor bed plus margins did not compromise outcomes in average-risk patients in the Children's Oncology Group (COG) <a href="/clinicaltrials/NCT00085735">ACNS0331 (NCT00085735)</a> study.[<a href="#cit/section_2.59">59</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810017&amp;version=HealthProfessional&amp;
        end
        134619
        exact text
        NCT00085735
        start
        134608
      2. context exact
        or bed plus margins did not compromise outcomes in average-risk patients in the Children's Oncology Group (COG) <a href="/clinicaltrials/NCT00085735">ACNS0331 (NCT00085735)</a> study.[<a href="#cit/section_2.59">59</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810017&amp;version=HealthProfessional&amp;language=English" oncli
        end
        134642
        exact text
        NCT00085735
        start
        134631
      3. context exact
        tion_2.124">124</a>]<p id="_2001" tabindex="-1">Lower doses and boost volume of craniospinal radiation were evaluated in a COG study (<a href="/clinicaltrials/NCT00085735">NCT00085735</a>). Children aged 3 to 7 years were randomly assigned to receive a craniospinal radiation dose of either 18 Gy or 23.4 Gy, as well as whole post
        end
        154458
        exact text
        NCT00085735
        start
        154447
      4. context exact
        24</a>]<p id="_2001" tabindex="-1">Lower doses and boost volume of craniospinal radiation were evaluated in a COG study (<a href="/clinicaltrials/NCT00085735">NCT00085735</a>). Children aged 3 to 7 years were randomly assigned to receive a craniospinal radiation dose of either 18 Gy or 23.4 Gy, as well as whole posterior fossa v
        end
        154471
        exact text
        NCT00085735
        start
        154460
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/c624023f106fb92848.html
      source file sha256
      de913ab66946021d86e1a340fa661ff24113f3971f951da28d63bf80bb39bcab
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:32.468847+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      a109f304435fe602fcc473ec0677179aced88fa575703245f69cd5d95cdd1ea1
      source title
      Childhood Medulloblastoma and Other Central Nervous System Embryonal Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 11, 2025
        datetime
        2025-04-11T12:00:00Z
        display
        April 11, 2025

    Preserved source evidence · Not medical advice