Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00895622
First received: May 7, 2009
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether observation is more effective than radiation therapy in treating patients with meningioma.

PURPOSE: This phase II trial is studying observation to see how well it works compared with radiation therapy in treating patients with grade I, grade II, or grade III meningioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Other: clinical observation
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival rate at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grades 2-5 acute (≤ 90 days from start of radiotherapy) adverse events (e.g., neurologic, ocular/visual, dermatologic/skin [excluding alopecia], or other adverse event) as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Grades 2-5 late (> 90 days from start of radiotherapy) adverse events (e.g., neurologic, ocular/visual, dermatologic/skin [excluding alopecia], or other adverse event) as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • MRI imaging predictors as assessed by central neuroradiology review at diagnosis, at any failure, and at 3 years [ Designated as safety issue: No ]
  • Adherence to protocol-specific target and normal tissue radiotherapy parameters [ Designated as safety issue: No ]
  • Concordance between central and parent institution histopathologic grading and subtyping [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: June 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group 1
Patients undergo observation.
Other: clinical observation
Patients undergo observation.
Experimental: Group 2
Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks.
Radiation: 3-dimensional conformal radiation therapy
Given once daily 5 days a week for 6 weeks
Radiation: intensity-modulated radiation therapy
Given once daily 5 days a week for 6 weeks
Experimental: Group 3
Patients undergo IMRT once daily 5 days a week for 6 weeks.
Radiation: intensity-modulated radiation therapy
Given once daily 5 days a week for 6 weeks

Detailed Description:

OBJECTIVES:

Primary

  • To estimate the rates of progression-free survival at 3 years in patients with low-risk meningioma undergoing observation and in patients with intermediate- or high-risk meningioma undergoing radiotherapy.

Secondary

  • To study the concordance, or lack thereof, between central and parent institution histopathologic diagnosis, grading, and subtyping.
  • To estimate the rates of overall survival at 3 years in these patients.
  • To estimate the incidence rates of acute and late adverse events ≥ grade 2 in patients with intermediate- or high-risk meningioma undergoing radiotherapy.
  • To evaluate MRI imaging predictors by central neuroradiology review at diagnosis, at any failure, and at 3 years.
  • To evaluate adherence to protocol-specific target and normal tissue radiotherapy parameters.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 groups according to risk.

  • Group 1 (low-risk disease): Patients undergo observation.
  • Group 2 (intermediate-risk disease): Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks.
  • Group 3 (high-risk disease): Patients undergo IMRT once daily 5 days a week for 6 weeks.

After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually for 10 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed meningioma, meeting 1 of the following criteria:

    • Low-risk disease, as defined by the following:

      • Newly diagnosed, WHO grade I disease that was gross totally resected (Simpson's grade I, II, or III resection with no residual nodular enhancement on postoperative imaging) or subtotally resected (residual nodular enhancement or Simpson grade IV or V resection)
    • Intermediate-risk disease, as defined by the following:

      • Newly diagnosed, WHO grade II disease that was gross totally resected OR recurrent WHO grade I disease irrespective of the resection extent
    • High-risk disease, as defined by 1 of the following:

      • Newly diagnosed or recurrent WHO grade III disease of any resection extent
      • Recurrent WHO grade II disease of any resection extent
      • Newly diagnosed, WHO grade II disease that was subtotally resected
  • Patients with newly diagnosed disease must have had a histologic diagnosis within the past 6 months AND have undergone pre- and post-operative MRIs within the past 3 months
  • Patients with recurrent/progressive intermediate- or high-risk disease who have not undergone recent surgery must have documentation of recurrence or progression by MRI within the past 3 months
  • No extracranial or multiple meningioma and/or hemangiopericytoma

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Negative pregnancy test (for patients enrolled in groups 2 or 3)
  • Fertile patients must use effective contraception (for patients enrolled in groups 2 or 3)
  • Able to receive gandolinium
  • No other invasive malignancy within the past 3 years except for nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active comorbidity including, but not limited to, any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial and/or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or respiratory illness requiring hospitalization or that would preclude study treatment
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • Known HIV positivity or AIDS, based upon the current CDC definition
    • No evidence of active connective tissue disorders (e.g., lupus erythematosus and/or scleroderma) (for patients enrolled in groups 2 or 3)
  • No other major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study treatment or informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to the scalp, cranium, brain, or skull base
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895622

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Services Foundation Recruiting
Phoenix, Arizona, United States, 85013
Contact: David G. Brachman, MD, FACRO     602-274-4484        
Arizona Cancer Center at University of Arizona Health Sciences Center Recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Clinical Trials Office - Arizona Cancer Center at University o     520-626-9008        
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent     877-UC-STUDY     ucstudy@uci.edu    
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
John Muir/Mt. Diablo Comprehensive Cancer Center Recruiting
Walnut Creek, California, United States, 94598
Contact: Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Ca     925-941-4246        
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center     203-785-5702        
United States, Florida
University of Florida Shands Cancer Center Recruiting
Gainesville, Florida, United States, 32610-0232
Contact: Clinical Trials Office - University of Florida Shands Cancer C     888-254-7581        
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese     800-456-7121     canceranswers@moffitt.org    
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Altanta, Georgia, United States, 30322
Contact: Ian R. Crocker     404-778-5180        
Emory Crawford Long Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Ian R. Crocker     404-686-4411        
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer     912-350-8568        
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
United States, Indiana
Methodist Cancer Center at Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Alexander M. Yeh, MD     317-962-3172        
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit     913-588-4709        
United States, Kentucky
Norton Suburban Hospital Recruiting
Louisville, Kentucky, United States, 40207
Contact: Aaron C. Spalding     502-893-1000        
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Recruiting
Scarborough, Maine, United States, 04074
Contact: Ian J. Bristol     207-885-7600        
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit     800-888-8823        
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive     800-865-1125        
Henry Ford Macomb Hospital Recruiting
Clinton Township, Michigan, United States, 48038
Contact: Eleanor M. Walker, MD     313-916-1021        
Josephine Ford Cancer Center at Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Eleanor M. Walker, MD     313-916-1021        
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo     313-343-3166        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center     517-364-2890        
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Swati Dutta     810-985-1484        
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw     989-776-8411        
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Swati Dutta     586-573-5757        
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Missouri
CCOP - Kansas City Recruiting
Kansas City, Missouri, United States, 64131
Contact: Rakesh Gaur, MD     816-823-0555        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Joseph R. Simpson, MD, PhD     314-362-8567        
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown     800-996-2663     research@billingsclinic.org    
United States, Nebraska
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tien-Shew W. Huang     402-354-5890        
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Weining K. Zhen, MD     402-552-3844        
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center     603-650-7609     cancerhelp@dartmouth.edu    
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Sameer Rafla-Demetrious, MD, PhD, FRCR, FACR, FRSM     718-780-3677        
CCOP - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Jana L. Fox     516-734-8954        
Highland Hospital of Rochester Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen     585-473-2200        
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen     585-275-5345        
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital     330-375-6101        
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: William F. Demas, MD     330-375-3557        
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214-3998
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C     614-566-4475        
Lake/University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: John H. Suh, MD     216-444-5574        
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a     717-531-3779     CTO@hmc.psu.edu    
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer     215-955-6084        
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni     843-792-9321        
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0361
Contact: Clinical Trials Office - University of Texas Medical Branch     409-772-1950        
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Richard L. Crownover     210-567-4777        
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Ali K. Choucair     801-507-3800        
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Recruiting
Ogden, Utah, United States, 84403
Contact: Clinical Trials Office - McKay-Dee Hospital Center     801-387-7426        
Dixie Regional Medical Center - East Campus Recruiting
Saint George, Utah, United States, 84770
Contact: Clinical Trials Office - Dixie Regional Medical Center - East     435-688-4167        
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: James M. Larner     434-924-9333        
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse     804-628-1939        
United States, Washington
University Cancer Center at University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: George E. Laramore, PhD, MD, FACR     206-598-4110        
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Jon D. Pollock, MD     304-243-3490        
United States, Wisconsin
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gregory M. Cooley, MD     414-433-8184        
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
UW Cancer Center Johnson Creek Recruiting
Johnson Creek, Wisconsin, United States, 53038
Contact: Steven P. Howard     920-699-3500        
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center     608-775-2385     cancerctr@gundluth.org    
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo     608-262-5223        
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Gregory M. Cooley, MD     414-433-8184        
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C     414-805-4380        
Regional Cancer Center at Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Clinical Trials Office - Regional Cancer Center at Oconomowoc     262-928-7878        
Door County Cancer Center at Door County Memorial Hospital Recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Contact: Gregory M. Cooley, MD     414-433-8184        
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C     262-928-7632        
Canada, Alberta
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Albert D. Murtha     780-432-8771        
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: William G. McMillan     905-387-9495        
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Barbara J. Fisher     519-685-8615        
Canada, Quebec
Hopital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Robert A. Moumdjian     514-281-6000        
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: David Roberge     514-398-1444        
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: C. Leland Rogers, MD Salt Lake Regional Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00895622     History of Changes
Other Study ID Numbers: CDR0000641815, RTOG-0539
Study First Received: May 7, 2009
Last Updated: April 6, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
adult anaplastic meningioma
adult papillary meningioma
recurrent adult brain tumor

Additional relevant MeSH terms:
Meningioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013