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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Notify MeKey information
Conditions
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
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
etoposide
Drugvincristine sulfate
Drugadjuvant therapy
Procedureconventional surgery
Procedureradiation therapy
RadiationPrimary outcomes
-
Event-free survival
-
Overall survival
-
Surgical operability
-
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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