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+11
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: October 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.370 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
No InterventionGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives