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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000063603 | |||
| CAN-NCIC-CE2 | |||
| E-R9402 | |||
| NCCTG-927252 | |||
| SWOG-9402 | |||
| INT-0149 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| North Central Cancer Treatment Group | NETWORK |
| SWOG Cancer Research Network | NETWORK |
| Eastern Cooperative Oncology Group |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy (RT) alone | Active Comparator | 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. |
|
| Intensive pre-treatment chemotherapy and radiation therapy | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lomustine | Drug |
| ||
| procarbazine hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| 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. |
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DISEASE CHARACTERISTICS:
Histologically proven unifocal or multifocal, supratentorial, 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
No evidence of spinal drop metastasis or spread to noncontiguous meninges
No tumor that is predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
No spinal cord tumors
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Gulf Coast | Mobile | Alabama | 36688 | United States | ||
| CCOP - Greater Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 19783377 | Result | Wang M, Cairncross G, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K, Souhami L, Laperriere N, Mehta M, Curran W; Radiation Therapy Oncology Group (RTOG); North Central Cancer Treatment Group (NCCTG); Southwest Oncology Group (SWOG); National Cancer Institute of Canada Clinical Trials Group (NCIC CTG); Eastern Cooperative Oncology Group (ECOG). Cognition and quality of life after chemotherapy plus radiotherapy (RT) vs. RT for pure and mixed anaplastic oligodendrogliomas: radiation therapy oncology group trial 9402. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):662-9. doi: 10.1016/j.ijrobp.2009.06.004. Epub 2009 Sep 23. | |
| 18371182 |
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| NETWORK |
| NCIC Clinical Trials Group | NETWORK |
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| Drug |
|
| vincristine sulfate | Drug |
|
| radiation therapy | Radiation |
|
| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona | 85012 | United States |
| Veterans Affairs Medical Center - Tucson | Tucson | Arizona | 85723 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | 72205 | United States |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte | California | 91010-3000 | United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033-0804 | United States |
| Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California | 90073 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | 94553 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| UCSF Cancer Center and Cancer Research Institute | San Francisco | California | 94143-0128 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80010 | United States |
| Veterans Affairs Medical Center - Denver | Denver | Colorado | 80220 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | 30905-5650 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813-2424 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859-5000 | United States |
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612-7323 | United States |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | 60612 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | 60141 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7353 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | United States |
| Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | 40502-2236 | United States |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | 40536-0084 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | 71130-3932 | United States |
| Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | 71130 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | 02130 | United States |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0912 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Veterans Affairs Medical Center - Detroit | Detroit | Michigan | 48201-1932 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Providence Hospital - Southfield | Southfield | Michigan | 48075-9975 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | 39531-2410 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | 39216 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | 64128 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| St. Louis University Health Sciences Center | St Louis | Missouri | 63110 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | 87108-5138 | United States |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | United States |
| Veterans Affairs Medical Center - Albany | Albany | New York | 12208 | United States |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | 45220-2288 | United States |
| Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | 45267-0501 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Kettering | Ohio | 45429 | United States |
| CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | 43623-3456 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | 73104 | United States |
| Veterans Affairs Medical Center - Portland | Portland | Oregon | 97207 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97225 | United States |
| OHSU Cancer Institute | Portland | Oregon | 97239 | United States |
| Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | 29401-5799 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234-6200 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| Veterans Affairs Medical Center - Houston | Houston | Texas | 77030 | United States |
| Texas Tech University Health Science Center | Lubbock | Texas | 79415 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284-7845 | United States |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | 78284 | United States |
| Veterans Affairs Medical Center - Temple | Temple | Texas | 76504 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112-5550 | United States |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431-5048 | United States |
| Result |
| Giannini C, Burger PC, Berkey BA, Cairncross JG, Jenkins RB, Mehta M, Curran WJ, Aldape K. Anaplastic oligodendroglial tumors: refining the correlation among histopathology, 1p 19q deletion and clinical outcome in Intergroup Radiation Therapy Oncology Group Trial 9402. Brain Pathol. 2008 Jul;18(3):360-9. doi: 10.1111/j.1750-3639.2008.00129.x. Epub 2008 Mar 26. |
| 16782910 | Result | Intergroup Radiation Therapy Oncology Group Trial 9402; Cairncross G, Berkey B, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K, Souhami L, Laperierre N, Mehta M, Curran W. Phase III trial of chemotherapy plus radiotherapy compared with radiotherapy alone for pure and mixed anaplastic oligodendroglioma: Intergroup Radiation Therapy Oncology Group Trial 9402. J Clin Oncol. 2006 Jun 20;24(18):2707-14. doi: 10.1200/JCO.2005.04.3414. |
| Result | 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. |
| Result | 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. |
| 11586105 | Result | Jenkins RB, Curran W, Scott CB, Cairncross G. Pilot evaluation of 1p and 19q deletions in anaplastic oligodendrogliomas collected by a national cooperative cancer treatment group. Am J Clin Oncol. 2001 Oct;24(5):506-8. doi: 10.1097/00000421-200110000-00018. |
| 35731991 | Derived | Lassman AB, Hoang-Xuan K, Polley MC, Brandes AA, Cairncross JG, Kros JM, Ashby LS, Taphoorn MJB, Souhami L, Dinjens WNM, Laack NN, Kouwenhoven MCM, Fink KL, French PJ, Macdonald DR, Lacombe D, Won M, Gorlia T, Mehta MP, van den Bent MJ. Joint Final Report of EORTC 26951 and RTOG 9402: Phase III Trials With Procarbazine, Lomustine, and Vincristine Chemotherapy for Anaplastic Oligodendroglial Tumors. J Clin Oncol. 2022 Aug 10;40(23):2539-2545. doi: 10.1200/JCO.21.02543. Epub 2022 Jun 22. |
| 23071247 | Derived | Cairncross G, Wang M, Shaw E, Jenkins R, Brachman D, Buckner J, Fink K, Souhami L, Laperriere N, Curran W, Mehta M. Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402. J Clin Oncol. 2013 Jan 20;31(3):337-43. doi: 10.1200/JCO.2012.43.2674. Epub 2012 Oct 15. |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D008130 | Lomustine |
| D011344 | Procarbazine |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D001549 | Benzamides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
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