drugset
drugset / Trial / NCT00027846

Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

NCT00027846 ↗

Phase 2 Completed 378 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.

Timeline

Start
2003-08
Primary completion
2010-01-01
Completion
2016-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 12.5 mg/kg Intravenous
Subject Carboplatin Small molecule 375 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 33 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Subject Etoposide Small molecule 1.7 mg/kg Oral
Subject Etoposide Small molecule 50 mg/m2 Oral
Subject Vincristine Small molecule 0.05 mg/kg Intravenous
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 7 mg/kg Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 200 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications

brain neoplasm