Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma
|ClinicalTrials.gov Identifier: NCT00052455|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: lomustine Drug: procarbazine hydrochloride Drug: temozolomide Drug: vincristine sulfate||Phase 3|
- Compare the efficacy of temozolomide vs procarbazine, lomustine, and vincristine, in terms of overall survival, in patients with recurrent malignant glioma.
- Compare progression-free survival of patients treated with these regimens.
- Compare progression-free survival at 12 weeks in patients treated with two different schedules of temozolomide.
- Compare the overall survival of patients treated with two different schedules of temozolomide.
- Compare toxic effects of two different schedules of temozolomide in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I:Patients are randomized to 1 of 2 treatment schedules:
- Schedule 1: Patients receive oral temozolomide once daily on days 1-5.
- Schedule 2:Patients receive oral temozolomide once daily on days 1-21. Treatment on both schedules repeats every 4 weeks for a maximum of 9 courses in the absence of disease progression or unacceptable toxicity.
- Arm II:Patients receive oral lomustine and vincristine IV on day 1 and oral procarbazine on days 1-21. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at 12 and 24 weeks.
Patients are followed every 12 weeks.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||September 2010|
- Overall survival
- Progression-free survival at 12 weeks (Arm II)
- Overall survival
- Quality of life as measured by EORTC QLQ-C30 and BTM
- Cost effectiveness
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052455
|Medical Research Council Clinical Trials Unit|
|London, England, United Kingdom, NW1 2DA|
|Study Chair:||Simon Clawson||Medical Research Council|