Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

Summary

The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Conditions

• Anaplastic Ependymoma
• Brain Ependymoma
• Cellular Ependymoma
• Clear Cell Ependymoma
• Ependymoma
• Papillary Ependymoma

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Patients undergo conformal radiotherapy

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

OTHER

Clinical Observation

Patients undergo observation

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC or IV

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

DRUG

Mesna

Given IV

DRUG

Vincristine

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Amy A Smith · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-07

Primary Completion

2021-12-31

Completion

2026-03-31

Countries

• United States
• Australia
• Canada
• New Zealand

Study Locations