Know Cancer

forgot password

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

Phase 2/Phase 3
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

Thank you

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


- 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


- 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



- 18 and over

Performance status:

- Karnofsky 60-100%


- For high-risk patients:

- Granulocyte count at least 1,500/mm^3

- Platelet count normal


- Bilirubin no greater than 2 times normal

- SGOT or SGPT no greater than 4 times normal

- Alkaline phosphatase no greater than 2 times normal


- Creatinine no greater than 2 times normal


- No chronic lung disease (unless DLCO at least 60%)


- Neurologic function score no greater than 3


- 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


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy to the head or neck (unless brain is clearly excluded, such as
radiotherapy for localized vocal cord cancer)


- Not specified

Type of Study:


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


United States: Federal Government

Study ID:




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