Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme
carmustine
+ radiation therapy
Astrocytome+12
+ Gliome
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the feasibility and toxicity of escalating doses of conformal radiotherapy planned with 3-D treatment planning plus carmustine in patients with glioblastoma multiforme. Determine dose/volume and dose/anatomic characteristics that influence radiotherapy-induced CNS (central nervous system) toxicity. Evaluate local control, survival, and failure patterns of these patients treated with high doses of conformal radiotherapy to gross disease. Correlate changes on cross-sectional diagnostic MRI imaging studies to clinical or biologic endpoints. OUTLINE: This is a dose-escalation study. Patients are stratified according to the planned target volume, i.e., gross residual tumor plus 3 mm (less than 75 cc vs at least 75 cc). Patients undergo radiotherapy over 15-30 minutes daily 5 days a week for 6-8 weeks. After 46 Gy of radiotherapy have been administered, patients undergo radiotherapy field reduction and are accrued into one of four dose levels. (Dose level 1 closed to accrual 1/16/01) All patients receive at least 33 radiation treatments. Each patient is evaluated for acute dose-limiting toxicity for 90 days from start of therapy. Patients also receive carmustine IV over 1-2 hours daily on days 1-3 for the first week of radiotherapy. Treatment repeats every 8 weeks for up to 6 courses. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within at least 5 months.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.40 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme with areas of necrosis as diagnosed by surgical biopsy or subtotal excision Supratentorial tumor Gross measurable residual disease No well-differentiated or anaplastic astrocytoma, multifocal glioma, or recurrent glioblastoma multiforme Therapy must begin within 5 weeks after surgery but within 1 week after registration CT or MRI scan preoperatively and MRI postoperatively prior to initiation of radiotherapy If undergoing a stereotactic-guided needle biopsy, not required to repeat MRI after procedure if the prebiopsy MRI is suitable for treatment planning Prior complete surgical resection of tumor allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamic oxaloacetic transaminase) no greater than 2 times normal Renal: BUN (blood urea nitrogen) no greater than 30 mg/dL Creatinine no greater than 1.8 mg/dL Pulmonary: Normal chest x-ray OR DLCO (carbon monoxide diffusing capacity) at least 60% predicted Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer Neurologic functional status 0-3 No major medical illness or psychiatric impairments that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head or neck Surgery: See Disease Characteristics
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 237 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOuvrir University of Alabama at Birmingham Comprehensive Cancer Center dans Google MapsComprehensive Cancer Institute of Huntsville
Huntsville, United StatesHuntsville Hospital System
Huntsville, United StatesMBCCOP - Gulf Coast
Mobile, United States