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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 >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006461
Enrollment
82
Registered
2003-01-27
Start date
2000-10-31
Completion date
Unknown
Last updated
2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated Childhood Medulloblastoma, Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

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.

Interventions

DRUGcisplatin

Given IV

DRUGcyclophosphamide

Given IV

DRUGvincristine sulfate

Given IV

DRUGetoposide

Given PO

PROCEDUREtherapeutic conventional surgery

Undergo surgery

RADIATION3-dimensional conformal radiation therapy

Undergo 3-dimensional conformal radiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Event-free survival rate1 year

Secondary

MeasureTime frame
Neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiationUp to 9 years
Acute and chronic toxicities associated with the treatment regimensUp to 9 years
Feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluationsUp to 9 years
Incidence of atypical teratoid and/or rhabdoid tumorUp to 9 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026