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Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor
This study has been completed.
Study NCT00006461   Information provided by National Cancer Institute (NCI)
First Received: November 6, 2000   Last Updated: February 6, 2009   History of Changes

November 6, 2000
February 6, 2009
October 2000
January 2009   (final data collection date for primary outcome measure)
Event-free survival rate at 1 year [ Designated as safety issue: No ]
Event-free survival rate at 1 year
Complete list of historical versions of study NCT00006461 on ClinicalTrials.gov Archive Site
  • Feasibility and safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Neuropsychological and neuroendocrine effects [ Designated as safety issue: No ]
  • Incidence of atypical teratoid and/or rhabdoid tumor [ Designated as safety issue: No ]
  • Feasibility and safety
  • Toxicity
  • Neuropsychological and neuroendocrine effects
  • Incidence of atypical teratoid and/or rhabdoid tumor
 
Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor
Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children Greater Than or Equal to 8 Months and Less Than 3 Years With Non-Metastatic Medulloblastoma: A Children's Oncology Group Phase III Study

RATIONALE: 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.

PURPOSE: 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.

OBJECTIVES:

  • Compare the efficacy of cyclophosphamide, vincristine, cisplatin, and etoposide followed by second-look surgery and focal conformal radiotherapy vs combination therapy administered on POG 9233 in terms of event-free survival rates in children with nonmetastatic medulloblastoma or posterior fossa primitive neuroectodermal tumor.
  • Assess the feasibility and safety of this treatment regimen in these patients.
  • Determine the acute and chronic toxicities of this regimen in these patients.
  • Determine the neuropsychological and neuroendocrine effects of this regimen in these patients.
  • Determine the incidence of atypical teratoid/rhabdoid tumor in these patients.

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.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Phase III
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: vincristine sulfate
  • Procedure: conventional surgery
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
65
 
January 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary medulloblastoma or posterior fossa primitive neuroectodermal tumor

    • Prior definitive tumor resection within 6 weeks of study
  • No evidence of metastases

PATIENT CHARACTERISTICS:

Age:

  • 8 months to 3 years

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Hemoglobin at least 10 g/dL
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • AST less than 2.5 times normal
  • Bilirubin less than 1.5 mg/dL

Renal:

  • Creatinine less than 1.2 mg/dL OR
  • Creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
Both
up to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Switzerland
 
NCT00006461
 
CDR0000068269, COG-P9934, POG-P9934
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: David Ashley, MBBS, FRACP, PhD Royal Children's Hospital
National Cancer Institute (NCI)
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP