Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma
Recruitment status was Recruiting
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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 |
- Progression-free survival rate at 3 years [ Designated as safety issue: No ]
- 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 |
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
Hide Study 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 | |
| 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