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Phase III Randomized Study of Intensive PCV (PCB/CCNU/VCR) Given Prior to Radiotherapy vs Upon Recurrence in Adults with Supratentorial Anaplastic Astrocytoma (Summary Last Modified 09/94)

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Closed

over 16

EORTC-26921

Objectives

I.  Compare survival and time to recurrence of adult supratentorial anaplastic 
astrocytoma treated with radiotherapy and with dose-intensive PCV 
(procarbazine, lomustine, vincristine) given as neoadjuvant chemotherapy 
(i.e., prior to radiotherapy) vs. at the time of recurrence.

II.  Determine the rate and duration of objective responses produced by PCV 
given prior to radiotherapy vs. after recurrence in these patients.

Entry Criteria

Disease Characteristics:


Histologically confirmed supratentorial anaplastic astrocytoma
  No more than 3 weeks since surgery, i.e., maximum resection
  by standard procedures or stereotactic biopsy

Prior/Concurrent Therapy:


No anticancer agents between surgery and study entry

Glucocorticoids should be discontinued as soon as possible
after surgery

Patient Characteristics:


Age:
  Over 16

Performance status:
  ECOG or Zubrod 0-2 (Karnofsky 60-100%)

Hematopoietic:
  WBC greater than 4,000
  Platelets greater than 100,000
  Hct greater than 30%

Hepatic:
  Bilirubin less than 2.0 mg/dl

Renal:
  Creatinine less than 1.5 mg/dl
  BUN less than 40 mg/dl

Other:
  No other major medical illness

Expected Enrollment

A total of 254 patients will be entered over a period of 5 years.

Outline

Randomized study.

Arm I:  3-Drug Combination Chemotherapy followed by Radiotherapy.  PCV:  
Procarbazine, PCB, NSC-77213; Lomustine, CCNU, NSC-79037; Vincristine, VCR, 
NSC-67574; followed by focal tumor irradiation using high-voltage photons or 
electrons.

Arm II:  Radiotherapy followed, at recurrence, by 3-Drug Combination 
Chemotherapy.  Tumor irradiation as in Arm I; followed, at tumor recurrence, 
by PCV.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

J. Hildebrand, MD, Protocol chair
Ph: 32-2-5553346
Email: neurolog@ulb.ac.be

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.