Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma
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|ClinicalTrials.gov Identifier: NCT00004224|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Official Title:||SIOP Study of Combined Modality Treatment in Childhood Ependymoma|
|Study Start Date :||January 1999|
|Actual Study Completion Date :||March 2008|
- Event-free survival
- Overall survival
- Surgical operability
- Response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004224
|Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia|
|Buenos Aires, Argentina, 1428|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Fondazione Istituto Nazionale dei Tumori|
|Milan, Italy, 20133|
|Erasmus MC - Sophia Children's Hospital|
|Rotterdam, Netherlands, 3015 GJ|
|Hospital Des Cruces|
|Vizcaya, Spain, 48|
|Gothenburg, Sweden, 41685|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Study Chair:||Richard Grundy, MD, PhD||Birmingham Children's Hospital|
|Study Chair:||Maura Massimino, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|