- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00053872
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery. It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma.
PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Compare the event-free survival rate in pediatric patients with standard-risk medulloblastoma treated with conventional vs hyperfractionated radiotherapy and vincristine followed by maintenance with cisplatin, lomustine, and vincristine.
- Compare the overall survival of patients treated with these regimens.
- Compare the pattern of relapse, especially local relapse (tumor bed or posterior fossa outside tumor bed), in patients treated with these regimens.
- Determine the toxicity of surgery and whether there are identifiable factors that correlate with toxicity in these patients.
- Determine the impact of any surgical complications on commencement of adjuvant therapy and event-free survival of these patients.
- Compare late sequelae, in terms of health status, endocrine deficiencies, and hearing loss, in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 28-40 days after surgical resection, patients undergo conventional fractionated radiotherapy once daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine IV once weekly for 8 weeks.
- Arm II: Beginning as in arm I, patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine as in arm I.
- Maintenance chemotherapy:Six weeks after completion of radiotherapy, all patients receive cisplatin IV over 6 hours and oral lomustine on day 1 and vincristine IV on days 1, 8, and 15. Treatment repeats every 6 weeks for 8 courses.
Patients are followed at least every 6 months for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 316 patients (158 per treatment arm) will be accrued for this study within 4 years.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Wuerzburg, Alemania, D-97080
- Universitaets - Kinderklinik Wuerzburg
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Leuven, Bélgica, B-3000
- U.Z. Gasthuisberg
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Vizcaya, España, 48
- Hospital de Cruces
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Paris, Francia, 75248
- Institut Curie Hopital
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Turin, Italia, 10126
- Ospedale Infantile Regina Margherita
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Amsterdam, Países Bajos, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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England
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Liverpool, England, Reino Unido, L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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Gothenburg, Suecia, 41685
- Östra sjukhuset
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed medulloblastoma, including the following variants:
- Classic
- Nodular/desmoplastic
- Large cell
- Melanotic
- Medullomyoblastoma
Prior total or subtotal surgical removal of tumor within the past 28-40 days
- No more than 1.5 cm^2 residual tumor by early postoperative MRI or CT scan
- No brainstem or supratentorial primitive neuroectodermal tumor
- No atypical teratoid rhabdoid tumor
- No known predisposition to medulloblastoma (e.g., Gorlin's syndrome)
- No CNS metastasis (supratentorial, arachnoid of the posterior fossa, or craniospinal axis) by MRI
- No clinical evidence of metastasis outside the CNS
- No tumor cells in lumbar cerebrospinal fluid by cytospin
PATIENT CHARACTERISTICS:
Age
- 3 to 21
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Hematological function less than CTC grade 2
Hepatic
- Liver function less than CTC grade 2
Renal
- Renal function less than CTC grade 2
Other
- Not pregnant
- Fertile patients must use effective contraception
- Able to receive radiotherapy twice daily
- Vital functions within age-appropriate normal range
- Audiological function less than CTC grade 2
- No medical contraindication to radiotherapy or chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Concurrent dexamethasone as an antiemetic allowed, provided all other therapies have failed
Radiotherapy
- No concurrent cobalt irradiation
Surgery
- See Disease Characteristics
Other
- No prior treatment for brain tumor or any other malignancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Comparison of event-free survival at 3 years
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Medidas de resultado secundarias
Medida de resultado |
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Comparison of overall survival
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Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed])
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Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies
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Toxicity of neurosurgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Brigitta Lannering, MD, PhD, Östra sjukhuset
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Glioma
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores Neuroectodérmicos Primitivos
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Meduloblastoma
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agentes antineoplásicos, fitogénicos
- Cisplatino
- Vincristina
- Lomustina
Otros números de identificación del estudio
- CDR0000269521
- SIOP-PNET-4
- EU-20244
- UKCCSG-CNS-2003-05
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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