Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors
Intervention: lomustine (Drug); procarbazine hydrochloride (Drug); vincristine (Drug); radiation therapy (Procedure)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Radiation Therapy Oncology Group Official(s) and/or principal investigator(s):
Edward G. Shaw, MD, Study Chair, Affiliation: Wake Forest University
Geoffrey R. Barger, MD, Study Chair, Affiliation: Barbara Ann Karmanos Cancer Institute
Jan C. Buckner, MD, Study Chair, Affiliation: Mayo Clinic
Minesh P. Mehta, MD, Study Chair, Affiliation: University of Wisconsin, Madison
Summary
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. It is not yet known whether radiation therapy combined with chemotherapy is more
effective than radiation therapy alone in treating patients with low-grade glioma.
PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of
radiation therapy with or without combination chemotherapy in treating patients with
low-grade glioma.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Active Control
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1998
Last updated: June 13, 2008
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