A Phase II Study of Observation in Favorable Low-Grade Glioma and a Phase II Study of Radiation With or Without PCV Chemotherapy in Unfavorable Low-Grade Glioma
radiation therapy
+ lomustine
+ procarbazine hydrochloride
Glioma+8
+ Neoplasias
+ Neoplasias por tipo histológico
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Identify the overall survival of low-risk adult patients with supratentorial low-grade glioma who are observed postoperatively. Compare the overall survival of high-risk adult patients with supratentorial low-grade glioma who receive postoperative external beam radiotherapy with or without procarbazine, lomustine, and vincristine (PCV) chemotherapy. Compare the toxic effects of postoperative radiotherapy with or without PCV chemotherapy in patients with unfavorable low-grade glioma. OUTLINE: This is a randomized study. Patients are stratified according to tumor subtype (astrocytoma [mixed-astro dominant or equal astro/oligo mix] vs oligodendroglioma [mixed-oligo dominant]), age (younger than 40 vs at least 40), Karnofsky performance status (60-80% vs 90-100%), and contrast enhancement on preoperative scan (present vs absent). Patients with low-risk disease (younger than 40 years old whose tumors have been surgically removed) are assigned to arm I. Patients with high-risk disease (at least 40 years old or who have had incomplete tumor removal) are randomized to arm II or III. Arm I (low-risk patients): Patients are observed. Patients may receive treatment if tumor recurs. Arm II (high-risk patients): Patients receive daily external beam radiotherapy 5 days a week for 6 weeks. Arm III (high-risk patients): Patients receive radiotherapy as in arm II followed by chemotherapy 1 month later. Chemotherapy consists of oral lomustine on day 1, vincristine IV on days 8 and 29, and oral procarbazine on days 8-21. Each course of chemotherapy lasts 8 weeks. Patients may receive up to 6 courses of chemotherapy. Patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 252 patients will be accrued within 5.25 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 370 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 120 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed unifocal or multifocal supratentorial WHO grade II astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic), oligodendroglioma, or oligoastrocytoma Patients with neurofibromatosis are eligible No other low-grade histologies, including: Pilocytic astrocytoma Subependymal giant cell astrocytoma of tuberous sclerosis Subependymoma Pleomorphic xanthoastrocytoma Presence of a neuronal element such as ganglioglioma Dysneuroembryoplastic epithelial tumor No presence of any high-grade glioma, including: Anaplastic astrocytoma Glioblastoma multiforme Anaplastic oligodendroglioma Anaplastic oligoastrocytoma No tumors in nonsupratentorial or other locations including optic chiasm, optic nerve(s), pons, medulla, cerebellum, or spinal cord No evidence of spread to spinal meninges or noncontiguous cranial meninges (i.e., leptomeningeal gliomatosis) No gliomatosis cerebri PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: For high-risk patients: Granulocyte count at least 1,500/mm^3 Platelet count normal Hepatic: Bilirubin no greater than 2 times normal SGOT or SGPT no greater than 4 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 2 times normal Pulmonary: No chronic lung disease (unless DLCO at least 60%) Neurological: Neurologic function score no greater than 3 Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head or neck (unless brain is clearly excluded, such as radiotherapy for localized vocal cord cancer) Surgery: Not specified
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Sin IntervenciónGrupo II
ExperimentalGrupo III
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios