Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	15 and over		NCOG-6G61

Objectives

I.  Compare the effectiveness of radiotherapy plus hydroxyurea followed by 
BCNU vs. radiotherapy plus hydroxyurea followed by 
CCNU/procarbazine/vincristine for primary, intracranial, malignant glioma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 15 years old with 
biopsy-proven (or with clinical, neurological, and neuroradiological evidence 
that supports no other diagnosis) primary, intracranial, malignant glioma of 
the following types:  glioblastoma multiforme (closed to glioblastoma 
multiforme, June 1981), Grade III and IV astrocytoma, anaplastic astrocytoma, 
gemistocytic astrocytoma and malignant glioma (not otherwise specified).  
Patients must have:  a life expectancy of at least 8 weeks, BUN no greater 
than 30 mg% or creatinine no greater than 2 mg% (if both tests are done, the 
patient is eligible if creatinine does not exceed 2 mg%, regardless of BUN); 
WBC of at least 4,000 and/or granulocyte count of at least 2,000 (if both 
tests are done, the patient is eligible if the granulocyte count is at least 
2,000, regardless of WBC); platelet count of at least 125,000; bilirubin no 
greater than 1.2 mg% and SGOT and alkaline phosphatase no greater than twice 
the maximum institution normal.  Patients must not have had prior cytotoxic 
chemotherapy and radiotherapy (and must have a minimal Karnofsky rating of 
40%, per August 1978 addendum).

Expected Enrollment

200 patients will be entered in 2 years.  As of June 1981, 193 patients have 
been entered (107 with glioblastoma multiforme).  Protocol closed to patient 
entry.

Outline

Randomized study.
Arm I:  Radiotherapy plus Single-agent Chemotherapy followed by Single-agent 
Chemotherapy.  Megavoltage radiation to whole brain; plus Hydroxyurea, HU, 
NSC-32063; followed by BCNU, NSC-409962.
Arm II:  Radiotherapy plus Single-agent Chemotherapy followed by 3-Drug 
Combination Chemotherapy.  Radiotherapy as in Arm I; plus HU; followed by PCV: 
 Procarbazine, PCB, NSC-77213; CCNU, NSC-79037; Vincristine, VCR, NSC-67574.

Levin VA, Silver P, Hannigan J, et al.: Superiority of post-radiotherapy adjuvant chemotherapy with CCNU, procarbazine, and vincristine (PCV) over BCNU for anaplastic gliomas: NCOG 6G61 final report. Int J Radiat Oncol Biol Phys 18 (2): 321-4, 1990.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Clinical Research Program - Northern California Cancer Center

Robert Carlson, MD, Protocol chair		Ph: 650-725-6457; 800-756-9000