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Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Neurotoxicity

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed* supratentorial low-grade glioma, including 1 of the
following:

- Grade 2 astrocytoma

- Grade 2 oligodendroglioma

- Grade 2 oligoastrocytoma (mixed glioma containing astrocytoma and
oligodendroglioma)

- NOTE: *If the pathology from multiple procedures supports the diagnosis of a brain
tumor, the qualifying pathology of grade 2 astrocytoma, oligodendroglioma, or
oligoastrocytoma must be the most recent pathological diagnosis; no pathological
diagnosis of grade 3 or 4 glioma at any time

- Paraffin-embedded tumor specimen available for submission for confirmation of
pathological review and determination of 1p and 19q deletion status

- Patients must currently meet ≥ 1 of the following criteria*:

- Uncontrolled symptoms, defined as any of the following:

- Headaches associated with mass effect

- Uncontrolled seizures despite two different antiepileptic drug regimens
(i.e., two antiepileptic drugs tested either sequentially or in
combination)

- Focal neurological symptoms

- Cognitive symptoms or deficits

- Tumor progression by serial MRIs, defined as any of the following:

- New or progressive enhancement

- New or progressive T2 or FLAIR signal abnormality

- Age ≥ 40 years

- NOTE: *Patients < 40 years of age whose only symptom of low-grade glioma is seizures
that are well-controlled on antiepileptic drugs AND who have no evidence of
radiographic progression are not eligible.

- Patients who have undergone gross total resection and have no detectable residual
disease are eligible

- No pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or
dysembryoplastic neuroepithelial tumors

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- WBC ≥ 3,000/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hematocrit ≥ 30%

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- Creatinine ≤ 2.0 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Able to undergo MRI with and without contrast

- No other malignancy within the past 5 years, except for nonmelanoma skin cancer or
cervical carcinoma in situ

- No uncontrolled infection

- No known HIV positivity

- No medical disorder that would increase risks associated with radiotherapy and
temozolomide

- No other disorder that would limit life expectancy to < 5 years

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy, cytotoxic chemotherapy, radiosurgery, or investigational
therapy directed at the brain tumor

- Any number of prior surgical procedures for the brain tumor allowed

- No prior radiotherapy to the head unless the radiotherapy ports entirely excluded the
brain

- At least 2 weeks since any prior brain surgery (e.g., stereotatic biopsy, open
biopsy, or resection)

- At least 6 weeks since prior MRI and chest x-ray

- If resection is performed, an MRI after surgery is required

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Safety Issue:

No

Principal Investigator

David Schiff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia

Authority:

Unspecified

Study ID:

CDR0000654697

NCT ID:

NCT00978458

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neurotoxicity
  • neurotoxicity
  • adult diffuse astrocytoma
  • adult oligodendroglioma
  • recurrent adult brain tumor
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neurotoxicity Syndromes

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
Genesys Hurley Cancer InstituteFlint, Michigan  48503
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
University of Illinois Cancer CenterChicago, Illinois  60612-7243
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Valley Cancer CenterSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
St. Anthony Central HospitalDenver, Colorado  80204-1335
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Resource Center - LincolnLincoln, Nebraska  68510
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Evanston HospitalEvanston, Illinois  60201-1781
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Billings Clinic - DowntownBillings, Montana  59107-7000
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Legacy Salmon Creek Medical CenterVancouver, Washington  98686
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Diagnostic and Treatment CenterWeston, Wisconsin  54476
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Parkview Regional Cancer Center at Parkview HealthFort Wayne, Indiana  46805
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Theda Care Cancer InstituteAppleton, Wisconsin  54911
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
La Grange Memorial HospitalLa Grange, Illinois  60525
Louisville Oncology at Norton Cancer Institute - LouisvilleLouisville, Kentucky  40202
Galesburg Clinic, PCGalesburg, Illinois  61401
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - CarthageCarthage, Illinois  62321
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - HavanaHavana, Illinois  62644
Illinois CancerCare - Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare - MacombMacomb, Illinois  61455
OSF Holy Family Medical CenterMonmouth, Illinois  61462
Illinois CancerCare - MonmouthMonmouth, Illinois  61462
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - PrincetonPrinceton, Illinois  61356
Illinois CancerCare - Spring ValleySpring Valley, Illinois  61362
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211
Cancer Centers of the Carolinas - Greer Radiation OncologyGreer, South Carolina  29650
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
New York Oncology Hematology, PC at Albany Medical CenterAlbany, New York  12208
Community Regional Cancer Care at Community Hospital NorthIndianapolis, Indiana  46256
Community Regional Cancer Care at Community Hospital EastIndianapolis, Indiana  46219
Radiation Oncology Associates SouthwestFort Wayne, Indiana  46804
Nebraska Medical CenterOmaha, Nebraska  68198
Norton Suburban HospitalLouisville, Kentucky  40207