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NCT00006461 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor

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
2013-08-09

This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use 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 more than one drug and combining chemotherapy with surgery and radiation therapy may kill more tumor cells.

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.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed primary medulloblastoma or posterior fossa primitive neuroectodermal tumor * Prior definitive tumor resection within 6 weeks of study * No evidence of metastases * Hemoglobin at least 10 g/dL * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * AST less than 2.5 times normal * Bilirubin less than 1.5 mg/dL * Creatinine less than 1.2 mg/dL * Creatinine clearance greater than 70 mL/min * No prior chemotherapy * No prior radiotherapy * See Disease Characteristics
healthy Volunteers
false
maximum Age
3 Years
sex
ALL
std Ages
  1. CHILD
Treatment arms and interventions
arm Groups
  1. description
    Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
    intervention Names
    1. Drug: cisplatin
    2. Drug: cyclophosphamide
    3. Drug: vincristine sulfate
    4. Drug: etoposide
    5. Procedure: therapeutic conventional surgery
    6. Radiation: 3-dimensional conformal radiation therapy
    label
    Chemotherapy, surgery, radiation therapy
    type
    OTHER
interventions
  1. arm Group Labels
    1. Chemotherapy, surgery, radiation therapy
    description
    Given IV
    name
    cisplatin
    other Names
    1. CACP
    2. CDDP
    3. CPDD
    4. DDP
    type
    DRUG
  2. arm Group Labels
    1. Chemotherapy, surgery, radiation therapy
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. CPM
    2. CTX
    3. Cytoxan
    4. Endoxan
    5. Endoxana
    type
    DRUG
  3. arm Group Labels
    1. Chemotherapy, surgery, radiation therapy
    description
    Given IV
    name
    vincristine sulfate
    other Names
    1. leurocristine sulfate
    2. VCR
    3. Vincasar PFS
    type
    DRUG
  4. arm Group Labels
    1. Chemotherapy, surgery, radiation therapy
    description
    Given PO
    name
    etoposide
    other Names
    1. EPEG
    2. VP-16
    3. VP-16-213
    type
    DRUG
  5. arm Group Labels
    1. Chemotherapy, surgery, radiation therapy
    description
    Undergo surgery
    name
    therapeutic conventional surgery
    type
    PROCEDURE
  6. arm Group Labels
    1. Chemotherapy, surgery, radiation therapy
    description
    Undergo 3-dimensional conformal radiation therapy
    name
    3-dimensional conformal radiation therapy
    other Names
    1. 3D conformal radiation therapy
    2. 3D-CRT
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
82
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Event-free survival rate
    time Frame
    1 year
secondary Outcomes
  1. measure
    Acute and chronic toxicities associated with the treatment regimens
    time Frame
    Up to 9 years
  2. measure
    Neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation
    time Frame
    Up to 9 years
  3. measure
    Feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations
    time Frame
    Up to 9 years
  4. measure
    Incidence of atypical teratoid and/or rhabdoid tumor
    time Frame
    Up to 9 years
Full study description
brief Summary
This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use 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 more than one drug and combining chemotherapy with surgery and radiation therapy may kill more tumor cells.
detailed Description
PRIMARY OBJECTIVES: I. To determine if the proposed treatment for children \>= 8.0 months and \< 3 years of age at registration with non-metastatic (M0) medulloblastoma is more effective than the combined treatments given to children of the same age and extent of disease on POG 9233, as measured by event-free survival (EFS) rates. SECONDARY OBJECTIVES: I. To assess the feasibility and safety of the planned use of second look surgery and focal conformal radiation therapy following chemotherapy. II. To determine the acute and chronic toxicities associated with the above treatment regimens. III. To describe the neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation. IV. To determine the feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations. V. To determine the incidence of atypical teratoid/rhabdoid tumor (AT/RT) in children enrolled on this study. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy consisting of vincristine IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a second resection. Within 4 weeks after completion of induction chemotherapy or second resection, patients receive focal conformal radiotherapy daily, 5 days a week, for 6 weeks. Four weeks after completion of radiotherapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Source references
Source notices and limitations
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        h medulloblastoma denoted as intermediate risk (5-year EFS rate, 25% &#177; 12%).[<a href="#cit/section_2.65">65</a>]</li><li>The COG <a href="/clinicaltrials/NCT00006461">P9934 (NCT00006461)</a> study, which also employed focal radiation therapy, had a similar EFS (4-year EFS rate, 23% &#177; 12%) for patients with nondesmoplas
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        noted as intermediate risk (5-year EFS rate, 25% &#177; 12%).[<a href="#cit/section_2.65">65</a>]</li><li>The COG <a href="/clinicaltrials/NCT00006461">P9934 (NCT00006461)</a> study, which also employed focal radiation therapy, had a similar EFS (4-year EFS rate, 23% &#177; 12%) for patients with nondesmoplastic medulloblastoma.
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      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