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Clinical Trials (PDQ®)

Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Natural history/Epidemiology, Supportive careActive18 and overNCI, OtherRTOG 0925
NCI-2011-02982, CDR0000708271, U10CA037422, NCT01417507

Trial Description

Summary

This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if there is difference in the average changes of neurocognitive function (NCF) scores from baseline to the time of radiologic tumor progression or up to 5 years (whichever occurs first), between radiologically progressed and non-progressed patients.

SECONDARY OBJECTIVES:

I. To determine if there is difference in the time to neurocognitive decline, as defined by the Reliable Change Index - Within subjects Standard Deviation (RCI-WSD), between radiologically progressed and non-progressed patients.

II. To evaluate NCF during the postoperative observational period of progression-free survival (PFS) and after radiological progression for a total time on study of 5 years.

III. To determine if the changes in cognitive functioning are an early warning biomarker for radiological progression.

IV. To explore the effect of salvage therapy on cognitive outcomes in patients who progress during the study period for up to 5 years.

V. To evaluate quality-of-life (QOL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QOL-30 and QOL brain module (BCN20) and health utilities as measured by the European Quality of Life-5 Dimensions (EQ-5D), for a total time on study of 5 years.

VI. To evaluate seizure control for a total time on study of 5 years. VII. To evaluate molecular correlates of QOL, NCF, seizure control, and PFS. VIII. To characterize aberrant molecular pathways in low-grade gliomas (LGGs) and test the hypothesis that activation of signaling pathways will predict worse PFS and overall survival (OS).

IX. To explore the relationship between change in cognitive function and symptomatic progression (defined as worsening seizures or new or progressive neurologic deficits) or clinical progression (defined as initiation of treatment interventions such as radiotherapy, chemotherapy, or additional surgery).

OUTLINE:

Patients undergo neurocognitive assessment using the CogState Test battery (the Detection Test (DET), the Identification Test (IDN), the One Card Learning Test (OCLT), and the Groton Maze Learning Test (GMLT)) at baseline* and at 12, 24, 36, 42, 48, 54, and 60 months. Patients also complete the EORTC Quality of Life Questionnaire-Core 30 (QOL-30), the Brain Cancer Module-20 (BCM20), and the European Quality of Life-5 Dimensions (EQ-5D) questionnaires at baseline*, at 12, 24, 36, 48, and 60 months afterwards, and before undergoing any further treatment. Patients are instructed to complete a seizure and medication diary during study.

Patients undergo MRI scans at baseline*, at 12, 24, 36, 48, and 60 months, and at the time of radiological, clinical, or neurological failure.

NOTE: * 12 weeks after surgery.

Eligibility Criteria

Inclusion Criteria:

  • Central pathology confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma prior to step 2 registration
  • No multifocal disease, based upon the following minimum diagnostic work-up:
  • History/physical examination, including neurologic examination, within 84 days prior to step 2 registration
  • Brain MRI with and without contrast within 84 days prior to Step 2 registration (Note: MRI 70 days after surgery is preferred and highly encouraged)
  • The patient must be within one of the following categories:
  • Maximal safe resection with minimal residual disease defined as follows:
  • Removal of T2/fluid-attenuated inversion recovery (FLAIR) abnormalities thought to be primarily tumor, with a residual ≤ 2 cm maximal tumor diameter/T2 FLAIR abnormality on MRI to be done within 84 days post-operatively
  • If there is > 2 cm post-operative residual T2/FLAIR abnormality and the neurosurgeon believes this represents edema and not primarily tumor, the neurosurgeon is encouraged to repeat imaging within the allowed study period (up to 84 days post-operatively) to confirm resolution of edema
  • MRI at the time of enrollment must document a ≤ 2 cm residual maximal tumor diameter/T2 FLAIR abnormality
  • Patients who required a second surgery to obtain a maximal safe resection will be eligible if the second surgery is performed within 84 days of the initial diagnostic procedure
  • Age < 40 (any extent of resection)
  • Age < 50 and preoperative tumor diameter < 4 cm (any extent of resection)
  • Karnofsky performance status ≥ 80%
  • No prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years [1,095 days] (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Must be able to undergo MRI of the brain with gadolinium
  • No plans for adjuvant radiotherapy or chemotherapy after surgery
  • No more than 84 days (12 weeks) since prior surgery
  • No brain tumor recurrence
  • No prior brain tumor surgery, radiation therapy and/or chemotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Ali ChoucairPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 Kirklin Clinic at Acton Road
 John Fiveash Ph: 205-934-0309
 UAB Comprehensive Cancer Center
 John Fiveash Ph: 205-934-0309
Arizona
  Phoenix
 Arizona Oncology - Deer Valley Center
 Lynn S Ashby Ph: 800-360-6371
  Scottsdale
 Arizona Oncology Services Foundation
 Lynn S Ashby Ph: 800-360-6371
California
  Stanford
 Stanford Cancer Center
 Scott G Soltys Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
Colorado
  Boulder
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Adam Raben Ph: 302-733-6227
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Robert J Sollaccio Ph: 407-303-5623
Georgia
  Atlanta
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
 Winship Cancer Institute of Emory University
 Hui-Kuo G Shu Ph: 404-778-1868
Hawaii
  Ewa Beach
 Leeward Radiation Oncology
 Paul A. DeMare Ph: 808-545-8548
  Honolulu
 Cancer Research Center of Hawaii
 Paul A. DeMare Ph: 808-545-8548
 Hawaii Medical Center - East
 Paul A. DeMare Ph: 808-545-8548
 Queen's Cancer Institute at Queen's Medical Center
 Paul A. DeMare Ph: 808-545-8548
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Jeffrey J. Raizer Ph: 312-695-1301
  Email: cancer@northwestern.edu
Iowa
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Parvesh Kumar Ph: 913-588-4709
Kentucky
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Ali K Choucair Ph: 502-629-2500
 Norton Suburban Hospital
 Ali K Choucair Ph: 502-629-2500
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Nadia N Laack Ph: 507-538-7623
Missouri
  Saint Louis
 Barnes-Jewish West County Hospital
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nebraska
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Andrew O Wahl Ph: 800-999-5465
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Alan C. Hartford Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New York
  New Hyde Park
 Long Island Jewish Medical Center
 Jonathan P. S. Knisely Ph: 516-562-3467
 Monter Cancer Center of the North Shore-LIJ Health System
 Jonathan P. S. Knisely Ph: 516-562-3467
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Ashley L Sumrall Ph: 704-355-2884
Ohio
  Cincinnati
 University of Cincinnati
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  West Chester
 University Pointe
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
  Gettysburg
 Adams Cancer Center
 Amit B. Shah Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Amit B. Shah Ph: 877-441-7957
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 John M Varlotto Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  York
 WellSpan Health
 Amit B. Shah Ph: 877-441-7957
South Carolina
  Greenville
 Cancer Centers of the Carolinas - Andrews
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
Texas
  San Antonio
 University of Texas Health Science Center at San Antonio
 John R Floyd Ph: 210-567-0653
  Email: che@uthscsa.edu
Utah
  Cedar City
 Sandra L. Maxwell Cancer Center
 R. Jeffrey Lee Ph: 801-507-3950
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 R. Jeffrey Lee Ph: 801-507-3950
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Dennis C. Shrieve Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Mark G Malkin Ph: 804-628-1939
Wisconsin
  Green Bay
 St. Mary's Hospital Medical Center - Green Bay
 Gregory M. Cooley Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Gregory M. Cooley Ph: 920-433-8889
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Jennifer M Connelly Ph: 414-805-4380
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Wingate F. Clapper Ph: 262-928-7632
Canada
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Jeffrey N Greenspoon Ph: 905-387-9495
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 Jean-Paul Bahary Ph: 514-890-8000ext23611
  Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01417507
ClinicalTrials.gov processed this data on December 23, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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