Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
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|ClinicalTrials.gov Identifier: NCT00002569|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 18, 2018
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy||Phase 3|
- Compare the overall survival and time to tumor progression in patients with unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma treated with radiotherapy with or without procarbazine, lomustine, and vincristine (PCV).
- Compare the toxic effects of these 2 regimens in these patients.
- Compare the quality of life and neurologic function of patients treated with these 2 regimens.
OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 2 weeks after randomization, patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29 (PCV). Treatment continues every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning within 6 weeks after day 29 of course 4, patients undergo radiotherapy 5 days a week for 5.6 weeks followed by boost radiotherapy 5 days a week for 1 week.
- Arm II: Within 2 weeks after randomization, patients undergo radiotherapy as in arm I.
Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of study therapy.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study within 5.4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Intergroup Randomized Comparison of Radiation Alone vs. Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas|
|Actual Study Start Date :||July 1994|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||May 21, 2018|
Active Comparator: Radiation therapy (RT) alone
Radiation therapy (RT) alone - External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume.
Radiation: radiation therapy
Experimental: Intensive pre-treatment chemotherapy and radiation therapy
Intensive pre-treatment chemotherapy (Day 1 CCNU 130 mg/m2 p.o., Day 8 - Vincristine 1.4 mg/m2 i.v., Days 8-21 - Procarbazine 75 mg/m2 p.o., Day 29 - Vincristine 1.4 mg/m2 i.v.) followed by radiation therapy (External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume).
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
- Overall Survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]
- Time to tumor progression [ Time Frame: From randomization to date of progression or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]
- Frequency of severe (>= Grade 3) toxicities [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002569
|Study Chair:||J. Gregory Cairncross, MD||London Health Sciences Centre|
|Study Chair:||Steven R. Alberts, MD||Mayo Clinic|
|Study Chair:||Karen L. Fink, MD, PhD||Simmons Cancer Center|
|Study Chair:||Richard M. Hellman, MD||Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center|
|Study Chair:||Normand Laperriere, MD, FRCPC||Princess Margaret Hospital, Canada|