Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
OBJECTIVES:
Primary
- To determine whether the addition of temozolomide to fractionated radiotherapy improves
the progression-free survival (PFS) of patients with symptomatic or progressive
low-grade gliomas.
- To determine whether the addition of temozolomide to fractionated radiotherapy improves
the median overall survival (OS) of these patients.
Secondary
- To determine whether combination therapy with temozolomide and radiotherapy improves or
maintains cognition and quality of life compared to radiotherapy alone.
- To compare the toxicities (severe or worse [≥ grade 3]) of radiotherapy with vs without
temozolomide in these patients.
- To assess the impact of the presence or absence of 1p and 19q deletion on PFS and OS.
- To determine the impact of 1p and 19q status on PFS and OS of patients treated with
temozolomide.
- To create a tumor and tissue bank, including plasma and germ line DNA, within the ECOG
Pathology Coordinating Office.
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 40 years
vs ≥ 40 years), 1p and 19q status (both deleted vs either/both intact vs undeterminable),
pre-operative maximum tumor diameter (< 6 cm vs ≥ 6 cm [based on T2 or FLAIR MRI]),
Karnofsky performance status (60-70% vs 80-100%), and contrast enhancement on pre-treatment
MRI scan (present vs absent). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy
once daily 5 days a week for 5½ weeks (28 fractions).
- Arm II: Patients undergo radiotherapy as in arm I and receive concurrent oral
temozolomide once daily for 5½ weeks. Beginning 28 days after completion of
chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5.
Treatment with temozolomide repeats every 28 days for 12 courses in the absence of
disease progression or unacceptable toxicity.
Some patients undergo quality-of-life and neurocognitive (e.g., visual scanning speed,
divided attention, language, memory, and fine motor skills) assessments at baseline,
annually until disease progression, and at the time of disease progression.
Tumor tissue samples are collected at baseline for confirmation of diagnosis and
determination of 1p and 19q deletion status. Peripheral blood, serum, and additional tumor
tissue samples may be collected for further research studies.
After completion of study treatment, patients are followed up periodically for up to 15
years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Progression-free survival (PFS)
No
David Schiff, MD
Study Chair
University of Virginia
Unspecified
CDR0000654697
NCT00978458
September 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
Evanston Hospital | Evanston, Illinois 60201-1781 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Legacy Salmon Creek Medical Center | Vancouver, Washington 98686 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Diagnostic and Treatment Center | Weston, Wisconsin 54476 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Greer Medical Oncology | Greer, South Carolina 29650 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
La Grange Memorial Hospital | La Grange, Illinois 60525 |
Louisville Oncology at Norton Cancer Institute - Louisville | Louisville, Kentucky 40202 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Carthage | Carthage, Illinois 62321 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Havana | Havana, Illinois 62644 |
Illinois CancerCare - Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
OSF Holy Family Medical Center | Monmouth, Illinois 61462 |
Illinois CancerCare - Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Pekin | Pekin, Illinois 61603 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Princeton | Princeton, Illinois 61356 |
Illinois CancerCare - Spring Valley | Spring Valley, Illinois 61362 |
Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
Columbia-Saint Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
Cancer Centers of the Carolinas - Greer Radiation Oncology | Greer, South Carolina 29650 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
New York Oncology Hematology, PC at Albany Medical Center | Albany, New York 12208 |
Community Regional Cancer Care at Community Hospital North | Indianapolis, Indiana 46256 |
Community Regional Cancer Care at Community Hospital East | Indianapolis, Indiana 46219 |
Radiation Oncology Associates Southwest | Fort Wayne, Indiana 46804 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
Norton Suburban Hospital | Louisville, Kentucky 40207 |