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Completed

NCT Number: NCT00004224

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

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Key information

Age range

3 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

etoposide

Drug

vincristine sulfate

Drug

adjuvant therapy

Procedure

conventional surgery

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Event-free survival

  2. Overall survival

  3. Surgical operability

  4. Response rate

Sponsors and collaborators

Lead sponsor

Societe Internationale d'Oncologie Pediatrique

Other

Collaborators

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

Registry information

Official study title

SIOP Study of Combined Modality Treatment in Childhood Ependymoma

Important dates

Study start
1999
Study completion
2008
First posted
Jan 27, 2003
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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