|
||||||||||||||||||||||
|
|
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 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 Lead Organizations European Organization for Research and Treatment of Cancer
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. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |