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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Brief Summary

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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

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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.

Conditions

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Untreated Childhood Medulloblastoma Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy, surgery, radiation therapy

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.

Group Type OTHER

cisplatin

Intervention Type DRUG

Given IV

cyclophosphamide

Intervention Type DRUG

Given IV

vincristine sulfate

Intervention Type DRUG

Given IV

etoposide

Intervention Type DRUG

Given PO

therapeutic conventional surgery

Intervention Type PROCEDURE

Undergo surgery

3-dimensional conformal radiation therapy

Intervention Type RADIATION

Undergo 3-dimensional conformal radiation therapy

Interventions

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cisplatin

Given IV

Intervention Type DRUG

cyclophosphamide

Given IV

Intervention Type DRUG

vincristine sulfate

Given IV

Intervention Type DRUG

etoposide

Given PO

Intervention Type DRUG

therapeutic conventional surgery

Undergo surgery

Intervention Type PROCEDURE

3-dimensional conformal radiation therapy

Undergo 3-dimensional conformal radiation therapy

Intervention Type RADIATION

Other Intervention Names

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CACP CDDP CPDD DDP CPM CTX Cytoxan Endoxan Endoxana leurocristine sulfate VCR Vincasar PFS EPEG VP-16 VP-16-213 3D conformal radiation therapy 3D-CRT

Eligibility Criteria

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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

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Ashley

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Arcadia, California, United States

Site Status

Countries

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Australia Canada Netherlands New Zealand Puerto Rico Switzerland United States