CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 479 enrolled
Drug / intervention
Carboplatin +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01096368
NCT01096368Phase 3Completed

Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years

Children's Oncology Group·interventional·Posted Mar 31, 2010·Updated Apr 30, 2026

In Brief

A Phase 3 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Carboplatin, and 8 other interventions for Anaplastic Ependymoma and 5 related conditions. Completed, enrolled 479 participants across 209 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, United States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2010
Enrollment StartMay 7, 2010
Primary CompletionDec 31, 2021
Study CompletionMar 31, 2026
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 16.3 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Patients undergo conformal radiotherapy

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Clinical Observationother

Patients undergo observation

Cyclophosphamidedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given SC or IV

Laboratory Biomarker Analysisother

Optional correlative studies

Mesnadrug

Given IV

Vincristinedrug

Given IV