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Sponsors and Collaborators: |
Societe Internationale d'Oncologie Pediatrique Children's Cancer and Leukaemia Group Associazione Italiana Ematologia Oncologia Pediatrica |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004224 |
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 | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | SIOP Study of Combined Modality Treatment in Childhood Ependymoma |
Estimated Enrollment: | 65 |
Study Start Date: | January 1999 |
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.
Ages Eligible for Study: | 3 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven nonmetastatic intracranial ependymoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Argentina | |
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia | Recruiting |
Buenos Aires, Argentina, 1428 | |
Contact: Blanca D. Diez, MD 54-11-5777-3200 bdiez@fleni.org.ar | |
Canada, Ontario | |
Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Eric Bouffet, MD, MRCP 416-813-7457 eric.bouffet@sickkids.ca | |
Italy | |
Fondazione Istituto Nazionale dei Tumori | Recruiting |
Milan, Italy, 20133 | |
Contact: Maura Massimino, MD 39-02-239-02-593 maura.massimino@istitutotumori.mi.it | |
Netherlands | |
Erasmus MC - Sophia Children's Hospital | Recruiting |
Rotterdam, Netherlands, 3015 GJ | |
Contact: R. Reddingius, MD, PhD 31-10-463-6363 | |
Spain | |
Hospital Des Cruces | Recruiting |
Vizcaya, Spain, 48 | |
Contact: Aurora Navajas 34-94-600-6000 | |
Sweden | |
Ostra Sjukhuset | Recruiting |
Gothenburg, Sweden, 41685 | |
Contact: Brigitta Lannering, MD, PhD 46-31-343-5224 | |
United Kingdom, England | |
Birmingham Children's Hospital | Recruiting |
Birmingham, England, United Kingdom, B4 6NH | |
Contact: Richard Grundy, MD, PhD 44-121-333-8234 richard.grundy@nottingham.ac.uk |
Study Chair: | Richard Grundy, MD, PhD | Birmingham Children's Hospital |
Study Chair: | Richard Grundy, MD, PhD | Birmingham Children's Hospital |
Study Chair: | Maura Massimino, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Study ID Numbers: | CDR0000067465, SIOP-EPENDYMOMA-99, AIEOP-EPENDYMOMA-99, CCLG-EPENDYMOMA-99, EU-99001 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004224 History of Changes |
Health Authority: | Unspecified |
childhood infratentorial ependymoma childhood supratentorial ependymoma newly diagnosed childhood ependymoma |
Immunologic Factors Adjuvants, Immunologic Vincristine Antimitotic Agents Central Nervous System Neoplasms Cyclophosphamide Immunosuppressive Agents Etoposide phosphate Ependymoma Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Tubulin Modulators Neuroepithelioma Antineoplastic Agents, Alkylating Glioma Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Etoposide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Cyclophosphamide Ependymoma Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Alkylating Agents Nervous System Neoplasms Neoplasms by Histologic Type |
Mitosis Modulators Nervous System Diseases Vincristine Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |