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Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma

Phase 3
Completed
Conditions
Brain and Central Nervous System Tumors
Interventions
Registration Number
NCT00002569
Lead Sponsor
Radiation Therapy Oncology Group
Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
299
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Radiation therapy (RT) aloneradiation therapyRadiation therapy (RT) alone - External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume.
Intensive pre-treatment chemotherapy and radiation therapylomustineIntensive 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).
Intensive pre-treatment chemotherapy and radiation therapyvincristine sulfateIntensive 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).
Intensive pre-treatment chemotherapy and radiation therapyradiation therapyIntensive 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).
Intensive pre-treatment chemotherapy and radiation therapyprocarbazine hydrochlorideIntensive 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).
Primary Outcome Measures
NameTimeMethod
Overall SurvivalFrom randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Secondary Outcome Measures
NameTimeMethod
Time to tumor progressionFrom 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) toxicitiesFrom randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

Trial Locations

Locations (95)

MBCCOP - Gulf Coast

🇺🇸

Mobile, Alabama, United States

CCOP - Greater Phoenix

🇺🇸

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

🇺🇸

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

Arizona Cancer Center

🇺🇸

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan)

🇺🇸

Little Rock, Arkansas, United States

Cancer Center and Beckman Research Institute, City of Hope

🇺🇸

Duarte, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

🇺🇸

Los Angeles, California, United States

Veterans Affairs Medical Center - West Los Angeles

🇺🇸

Los Angeles, California, United States

Scroll for more (85 remaining)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States

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