A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV
Data Collection
Astrocytoma+15
+ Brain Diseases
+ Brain Neoplasms
Treatment Study
Summary
Study start date: October 1, 2002
Actual date on which the first participant was enrolled.OBJECTIVES: * 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma * WHO grade III or IV at diagnosis or relapse * Must have undergone primary therapy including radiotherapy * Must be in first recurrence confirmed by CT scan or MRI * Evaluable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-3 Life expectancy * At least 1 month Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Total and direct bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT or SGPT less than 3 times ULN * Alkaline phosphatase less than 2 times ULN Renal * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent serious illness * Considered fit to receive chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for glioma Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 2 months since prior radiotherapy * No prior radiosurgery, interstitial radiotherapy, or brachytherapy for glioma Surgery * Prior debulking surgery for recurrent disease allowed
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Medical Research Council Clinical Trials Unit
London, United KingdomOpen Medical Research Council Clinical Trials Unit in Google Maps