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| ID | Type | Description | Link |
|---|---|---|---|
| SIOP-EPENDYMOMA-99 | |||
| AIEOP-EPENDYMOMA-99 | |||
| CCLG-EPENDYMOMA-99 | |||
| EU-99001 |
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| Name | Class |
|---|---|
| Children's Cancer and Leukaemia Group | OTHER |
| Italian Association for Pediatric Hematology Oncology | OTHER |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | |||
| etoposide | Drug | |||
| vincristine sulfate | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | ||
| Overall survival | ||
| Surgical operability | ||
| Response rate |
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DISEASE CHARACTERISTICS:
Histologically proven nonmetastatic intracranial ependymoma
No myxopapillary ependymoma, subependymoma, or ependymoblastoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Grundy, MD, PhD | Birmingham Children's Hospital | Study Chair |
| Maura Massimino, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia | Buenos Aires | Buenos Aires | 1428 | Argentina | ||
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| Hospital for Sick Children |
| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |
| Fondazione Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| Erasmus MC - Sophia Children's Hospital | Rotterdam | 3015 GJ | Netherlands |
| Hospital Des Cruces | Vizcaya | 48 | Spain |
| Ostra Sjukhuset | Gothenburg | 41685 | Sweden |
| Birmingham Children's Hospital | Birmingham | England | B4 6NH | United Kingdom |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D014750 | Vincristine |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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