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
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 299 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.
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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).
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Drug: lomustine 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma
- Prior suspected or proven low-grade glioma allowed if current histologic proof of pure or mixed anaplastic oligodendroglioma
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Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation
- For mixed tumors, the non-oligodendroglial element must be astrocytic and the oligodendroglial or astroglial component may be anaplastic
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No evidence of spinal drop metastasis or spread to noncontiguous meninges
- MRI of spine not required for asymptomatic patients and patients not excluded based on pathologic evidence of local meningeal infiltration by underlying tumor
- No tumor that is predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
- No spinal cord tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times normal
- Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal
- Alkaline phosphatase no greater than 2 times normal
Renal:
- Creatinine no greater than 1.5 times normal
Pulmonary:
- No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO) is at least 60% predicted
Other:
- No active infection
- No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No concurrent steroids as antiemetics
- Concurrent steroids allowed to control central nervous system (CNS) symptoms due to tumor-associated or radiotherapy-associated cerebral edema
Radiotherapy:
- No prior radiotherapy to brain or head/neck
Surgery:
- Prior surgery allowed

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Radiation Therapy Oncology Group |
ClinicalTrials.gov Identifier: | NCT00002569 |
Other Study ID Numbers: |
RTOG-9402 CDR0000063603 CAN-NCIC-CE2 E-R9402 NCCTG-927252 SWOG-9402 INT-0149 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 18, 2018 |
Last Verified: | June 2018 |
adult anaplastic oligodendroglioma adult mixed glioma |
Nervous System Neoplasms Central Nervous System Neoplasms Oligodendroglioma Neoplasms by Site Neoplasms Nervous System Diseases Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Vincristine Lomustine Procarbazine Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |