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
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Edward G. Shaw, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CDR0000066367
NCT ID:
NCT00003375
Start Date:
October 1998
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult oligodendroglioma
- adult diffuse astrocytoma
- adult pilocytic astrocytoma
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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