Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00895622
First received: May 7, 2009
Last updated: October 23, 2013
Last verified: October 2013
  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 (IMRT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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 Radiation Therapy Oncology Group:

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

Secondary Outcome Measures:
  • Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: From start of radiation to 90 days ] [ Designated as safety issue: Yes ]
    Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown.

  • Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for late adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: From 91 days after start of radiation to death or 10 years, whichever is first ] [ Designated as safety issue: Yes ]
    Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for late adverse events as assessed by NCI CTCAE v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown.

  • Survival rate at 3 years [ Time Frame: From registration to 3 years ] [ Designated as safety issue: No ]
  • MRI imaging predictors as assessed by central neuroradiology review at diagnosis, at any failure, and at 3 years [ Time Frame: From registration to 3 years ] [ Designated as safety issue: No ]
  • Adherence to protocol-specific target and normal tissue radiotherapy parameters [ Time Frame: After treatment delivery ] [ Designated as safety issue: No ]
  • Concordance between central and parent institution histopathologic grading and subtyping [ Time Frame: From 4 weeks of block receipt for central review of eligibility. ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: June 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Patients undergo clinical 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
Patients undergo 3-dimensional conformal radiation therapy once daily 5 days a week for 6 weeks
Radiation: intensity-modulated radiation therapy (IMRT)
Patients undergo IMRT 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 (IMRT)
Patients undergo IMRT 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 gadolinium
  • 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 Centers for Disease Control (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895622

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
Mayo Clinic Hospital
Phoeniz, Arizona, United States, 85054
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Indiana
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
CCOP - Kansas City
Prairie Village, Kansas, United States, 66208
United States, Kentucky
Norton Suburban Hospital
Louisville, Kentucky, United States, 40207
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01107
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United Hospital
Saint Paul, Minnesota, United States, 55102
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United States, Missouri
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Highland Hospital of Rochester
Rochester, New York, United States, 14620
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, South Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States, 54235-1495
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1Y 4E9
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: C. Leland Rogers, MD Salt Lake Regional Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00895622     History of Changes
Other Study ID Numbers: RTOG-0539, CDR0000641815
Study First Received: May 7, 2009
Last Updated: October 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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:
Central Nervous System Neoplasms
Meningioma
Nervous System Neoplasms
Meningeal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014