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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002569
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 18, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
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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.


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

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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: lomustine
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

  • 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

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Investigators
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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
More Information
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Publications of Results:
Cairncross JG, Wang M, Shaw EG, et al.: Chemotherapy plus radiotherapy (CT-RT) versus RT alone for patients with anaplastic oligodendroglioma: long-term results of the RTOG 9402 phase III study. [Abstract] J Clin Oncol 30 (Suppl 15): A-2008b, 2012.
Cairncross G, Seiferheld W, Shaw E, et al.: An intergroup randomized controlled clinical trial (RCT) of chemotherapy plus radiation (RT) versus RT alone for pure and mixed anaplastic oligodendrogliomas: initial report of RTOG 94-02. [Abstract] J Clin Oncol 22 (Suppl 14): A-1500, 107s, 2004.
Shaw EG, Seiferheld W, Cairncross JG, et al.: Radiation therapy (RT) alone vs intensive procarbazine-CCNU-vincristine (I-PCV) chemotherapy followed by radiation therapy for anaplastic oligodendroglioma (AO) and mixed oligo-astrocytoma (MOA): results of Radiation Therapy Oncology Group (RTOG) - intergroup protocol 94-02. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-57, S163, 2004.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Radiation Therapy Oncology Group:
adult anaplastic oligodendroglioma
adult mixed glioma
Additional relevant MeSH terms:
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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