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

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002569
Collaborator
National Cancer Institute (NCI) (NIH), North Central Cancer Treatment Group (Other), Southwest Oncology Group (Other), Eastern Cooperative Oncology Group (Other), NCIC Clinical Trials Group (Other)
299
Enrollment
95
Locations
2
Arms
286.7
Actual Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Jul 1, 1994
Actual Primary Completion Date :
Feb 1, 2005
Actual Study Completion Date :
May 21, 2018

Arms and Interventions

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

Primary Outcome Measures

  1. Overall Survival [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 [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 [From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 MBCCOP - Gulf Coast Mobile Alabama United States 36688
2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
3 Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix Arizona United States 85012
4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
5 Arizona Cancer Center Tucson Arizona United States 85724
6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
8 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
9 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
10 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
11 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
12 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
13 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
14 Chao Family Comprehensive Cancer Center Orange California United States 92868
15 University of California Davis Medical Center Sacramento California United States 95817
16 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
17 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
18 David Grant Medical Center Travis Air Force Base California United States 94535
19 University of Colorado Cancer Center Denver Colorado United States 80010
20 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
21 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
22 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
23 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813-2424
24 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
25 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
26 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
27 CCOP - Central Illinois Decatur Illinois United States 62526
28 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
29 Loyola University Medical Center Maywood Illinois United States 60153
30 University of Kansas Medical Center Kansas City Kansas United States 66160-7353
31 CCOP - Wichita Wichita Kansas United States 67214-3882
32 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
33 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40502-2236
34 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
35 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
36 Tulane University School of Medicine New Orleans Louisiana United States 70112
37 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
38 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
39 Boston Medical Center Boston Massachusetts United States 02118
40 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
41 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
42 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
43 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0912
44 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
45 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
46 Henry Ford Hospital Detroit Michigan United States 48202
47 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
48 CCOP - Duluth Duluth Minnesota United States 55805
49 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
50 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
51 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
52 Keesler Medical Center - Keesler AFB Keesler Air Force Base Mississippi United States 39534-2576
53 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
54 CCOP - Kansas City Kansas City Missouri United States 64131
55 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110
56 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
57 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
58 CCOP - Montana Cancer Consortium Billings Montana United States 59101
59 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
60 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
61 Veterans Affairs Medical Center - Albany Albany New York United States 12208
62 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
63 University of Rochester Medical Center Rochester New York United States 14642
64 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
65 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
66 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45267-0501
67 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
68 CCOP - Columbus Columbus Ohio United States 43206
69 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
70 CCOP - Dayton Kettering Ohio United States 45429
71 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
72 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
73 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
74 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
75 CCOP - Columbia River Program Portland Oregon United States 97225
76 OHSU Cancer Institute Portland Oregon United States 97239
77 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
78 Medical University of South Carolina Charleston South Carolina United States 29425-0721
79 CCOP - Greenville Greenville South Carolina United States 29615
80 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
81 Brooke Army Medical Center Fort Sam Houston Texas United States 78234-6200
82 University of Texas Medical Branch Galveston Texas United States 77555-0565
83 Veterans Affairs Medical Center - Houston Houston Texas United States 77030
84 Texas Tech University Health Science Center Lubbock Texas United States 79415
85 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7845
86 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
87 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
88 CCOP - Scott and White Hospital Temple Texas United States 76508
89 Huntsman Cancer Institute Salt Lake City Utah United States 84112-5550
90 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
91 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
92 Swedish Cancer Institute Seattle Washington United States 98104
93 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
94 CCOP - Northwest Tacoma Washington United States 98405-0986
95 Madigan Army Medical Center Tacoma Washington United States 98431-5048

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

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 27, 2003
Last Update Posted:
Jun 18, 2018
Last Verified:
Jun 1, 2018
Keywords provided by Radiation Therapy Oncology Group
adult anaplastic oligodendroglioma
adult mixed glioma
Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Oligodendroglioma
Vincristine
Lomustine
Procarbazine

Study Results

No Results Posted as of Jun 18, 2018