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Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 3 years

Safety Issue:

No

Principal Investigator

C. Leland Rogers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Salt Lake Regional Medical Center

Authority:

Unspecified

Study ID:

CDR0000641815

NCT ID:

NCT00895622

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult grade I meningioma
  • adult grade II meningioma
  • adult grade III meningioma
  • adult anaplastic meningioma
  • adult papillary meningioma
  • recurrent adult brain tumor
  • Meningioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - North Shore University HospitalManhasset, New York  11030
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
New York Methodist HospitalBrooklyn, New York  11215-3609
University of Texas Medical BranchGalveston, Texas  77555-1329
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Yale Cancer CenterNew Haven, Connecticut  06520-8028
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
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
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
Highland Hospital of RochesterRochester, New York  14620
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
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
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
UW Cancer Center Johnson CreekJohnson Creek, Wisconsin  53038
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Regional Cancer Center at Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
Emory Crawford Long HospitalAtlanta, Georgia  30308
Henry Ford Macomb HospitalClinton Township, Michigan  48038
Nebraska Medical CenterOmaha, Nebraska  68198
Norton Suburban HospitalLouisville, Kentucky  40207
Door County Cancer Center at Door County Memorial HospitalSturgeon Bay, Wisconsin  54235-1495