NCT00004224

Brief Summary

RATIONALE: 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 radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_2

Geographic Reach
7 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 26, 2013

Status Verified

April 1, 2008

First QC Date

January 28, 2000

Last Update Submit

August 23, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymomachildhood supratentorial ependymomanewly diagnosed childhood ependymoma

Outcome Measures

Primary Outcomes (4)

  • Event-free survival

  • Overall survival

  • Surgical operability

  • Response rate

Interventions

cyclophosphamideDRUG
etoposideDRUG
vincristine sulfateDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age3 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically proven nonmetastatic intracranial ependymoma * Cellular * Papillary * Clear cell * Mixed cell * Anaplastic * No myxopapillary ependymoma, subependymoma, or ependymoblastoma PATIENT CHARACTERISTICS: Age: * 3 to 20 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * No hematologic disease that would preclude study participation Hepatic: * Not specified Renal: * No renal disease that would preclude study participation Other: * No concurrent unrelated disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior steroids allowed Radiotherapy: * No prior radiotherapy Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia

Buenos Aires, Buenos Aires, 1428, Argentina

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Fondazione Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

Location

Hospital Des Cruces

Vizcaya, 48, Spain

Location

Ostra Sjukhuset

Gothenburg, 41685, Sweden

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

CyclophosphamideEtoposideVincristineChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Richard Grundy, MD, PhD

    Birmingham Children's Hospital

    STUDY CHAIR

  • Maura Massimino, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2000

First Posted

January 27, 2003

Study Start

January 1, 1999

Study Completion

March 1, 2008

Last Updated

August 26, 2013

Record last verified: 2008-04

Locations

ES(1)NL(1)SE(1)GB(1)AR(1)CA(1)IT(1)