Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma

August 23, 2013 updated by: Societe Internationale d'Oncologie Pediatrique

SIOP Study of Combined Modality Treatment in Childhood Ependymoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy.
  • Determine the response rate in these patients to this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy.

Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended.

Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery.

Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1428
        • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital For Sick Children
  • Italy
      • Milan, Italy, 20133
        • Fondazione Istituto Nazionale dei Tumori
  • Netherlands
      • Rotterdam, Netherlands, 3015 GJ
        • Erasmus MC - Sophia Children's Hospital
  • Spain
      • Vizcaya, Spain, 48
        • Hospital Des Cruces
  • Sweden
      • Gothenburg, Sweden, 41685
        • Östra sjukhuset
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Birmingham Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate
Overall survival
Event-free survival
Surgical operability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societe Internationale d'Oncologie Pediatrique

Collaborators

Children's Cancer and Leukaemia Group
Italian Association for Pediatric Hematology Oncology

Investigators

  • Study Chair: Richard Grundy, MD, PhD, Birmingham Children's Hospital
  • Study Chair: Maura Massimino, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 28, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067465
  • SIOP-EPENDYMOMA-99
  • AIEOP-EPENDYMOMA-99
  • CCLG-EPENDYMOMA-99
  • EU-99001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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