Intracranial Meningioma Clinical Trial
Official title:
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Status | Recruiting |
Enrollment | 148 |
Est. completion date | August 31, 2027 |
Est. primary completion date | June 15, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - PRIOR TO STEP 1 REGISTRATION: - The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution; WHO grade will be assigned according to WHO 2016 criteria - Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings - Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection - For step 1 registration the operating neurosurgeon must provide the modified Simpson grade - GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry - If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study - NOTE: Central pathology review must occur between steps 1 and 2 of registration; once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization - PRIOR TO STEP 2 REGISTRATION: - Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration - History/physical examination, including neurologic examination within 60 days prior to step 2 registration - Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration - If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception Exclusion Criteria: - Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma - Definitive evidence of metastatic meningioma - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible) - Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas - Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to: - Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration - Transmural myocardial infarction within the last 6 months prior to step 2 registration - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration - Type II neurofibromatosis (NF2) - Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 2 registration - Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, etc) or receive gadolinium; note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia - Pregnancy and/or nursing females |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario |
Canada | London Regional Cancer Program | London | Ontario |
Canada | CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | University Health Network-Princess Margaret Hospital | Toronto | Ontario |
India | Tata Memorial Hospital | Mumbai | |
Japan | Hiroshima University Hospital | Hiroshima City | |
Japan | Kyorin University Hospital | Mitaka-shi | Tokyo |
Japan | Saitama Medical University International Medical Center | Saitama | |
Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
Japan | Keio University | Shinjuku-ku | Tokyo |
Japan | Iwate Medical University Hospital | Shiwa-gun | Iwate |
Japan | National Cancer Center Hospital | Tokyo | |
Saudi Arabia | King Faisal Specialist Hospital and Research Centre | Riyadh | |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah |
United States | Kaiser Permanente-Anaheim | Anaheim | California |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Langlade Hospital and Cancer Center | Antigo | Wisconsin |
United States | Emory Proton Therapy Center | Atlanta | Georgia |
United States | Emory Saint Joseph's Hospital | Atlanta | Georgia |
United States | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia |
United States | Grady Health System | Atlanta | Georgia |
United States | Northside Hospital | Atlanta | Georgia |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | Maryland Proton Treatment Center | Baltimore | Maryland |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey |
United States | MaineHealth Coastal Cancer Treatment Center | Bath | Maine |
United States | Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Boca Raton Regional Hospital | Boca Raton | Florida |
United States | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York |
United States | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Saint Joseph Mercy Chelsea | Chelsea | Michigan |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Illinois | Chicago | Illinois |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan |
United States | MU Health - University Hospital/Ellis Fischel Cancer Center | Columbia | Missouri |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Memorial Sloan Kettering Commack | Commack | New York |
United States | UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida |
United States | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri |
United States | Northside Hospital-Forsyth | Cumming | Georgia |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Ascension Saint John Hospital | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Kaiser Permanente Dublin | Dublin | California |
United States | Essentia Health Cancer Center | Duluth | Minnesota |
United States | Miller-Dwan Hospital | Duluth | Minnesota |
United States | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin |
United States | Mercy Cancer Center-Elyria | Elyria | Ohio |
United States | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois |
United States | Piedmont Fayette Hospital | Fayetteville | Georgia |
United States | The New York Hospital Medical Center of Queens | Flushing | New York |
United States | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois |
United States | NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Faris | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Greer | Greer | South Carolina |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Memorial Sloan Kettering Westchester | Harrison | New York |
United States | Hartford Hospital | Hartford | Connecticut |
United States | NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | IU Health Methodist Hospital | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania |
United States | Lewistown Hospital | Lewistown | Pennsylvania |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan |
United States | Logan Regional Hospital | Logan | Utah |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | Los Angeles General Medical Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin |
United States | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio |
United States | Miami Cancer Institute | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Memorial Medical Center | Modesto | California |
United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
United States | Intermountain Medical Center | Murray | Utah |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Yale University | New Haven | Connecticut |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | NYP/Weill Cornell Medical Center | New York | New York |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Helen F Graham Cancer Center | Newark | Delaware |
United States | Rutgers New Jersey Medical School | Newark | New Jersey |
United States | Piedmont Newnan Hospital | Newnan | Georgia |
United States | Drexel Town Square Health Center | Oak Creek | Wisconsin |
United States | Kaiser Permanente Oakland-Broadway | Oakland | California |
United States | McKay-Dee Hospital Center | Ogden | Utah |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Kaiser Permanente-Ontario | Ontario | California |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | AdventHealth East Orlando | Orlando | Florida |
United States | AdventHealth Orlando | Orlando | Florida |
United States | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas |
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
United States | Capital Health Medical Center-Hopewell | Pennington | New Jersey |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Mayo Clinic Hospital in Arizona | Phoenix | Arizona |
United States | Saint Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon |
United States | Maine Medical Center-Bramhall Campus | Portland | Maine |
United States | Geisinger Cancer Services-Pottsville | Pottsville | Pennsylvania |
United States | Utah Valley Regional Medical Center | Provo | Utah |
United States | Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California |
United States | Beebe Health Campus | Rehoboth Beach | Delaware |
United States | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Riverton Hospital | Riverton | Utah |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Rohnert Park Cancer Center | Rohnert Park | California |
United States | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California |
United States | The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California |
United States | South Sacramento Cancer Center | Sacramento | California |
United States | Sutter Medical Center Sacramento | Sacramento | California |
United States | Ascension Saint Mary's Hospital | Saginaw | Michigan |
United States | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont |
United States | Siteman Cancer Center-South County | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri |
United States | LDS Hospital | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | MaineHealth Cancer Care Center of York County | Sanford | Maine |
United States | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California |
United States | Maine Medical Center- Scarborough Campus | Scarborough | Maine |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | TidalHealth Nanticoke / Allen Cancer Center | Seaford | Delaware |
United States | University of Washington Medical Center - Montlake | Seattle | Washington |
United States | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina |
United States | LSU Health Sciences Center at Shreveport | Shreveport | Louisiana |
United States | ProCure Proton Therapy Center-Somerset | Somerset | New Jersey |
United States | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey |
United States | Kaiser Permanente Cancer Treatment Center | South San Francisco | California |
United States | Ascension Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin |
United States | Piedmont Henry Hospital | Stockbridge | Georgia |
United States | ProMedica Flower Hospital | Sylvania | Ohio |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | Banner University Medical Center - Tucson | Tucson | Arizona |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | University of Arizona Cancer Center-Orange Grove Campus | Tucson | Arizona |
United States | Memorial Sloan Kettering Nassau | Uniondale | New York |
United States | Westchester Medical Center | Valhalla | New York |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | Legacy Salmon Creek Hospital | Vancouver | Washington |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois |
United States | Aspirus Regional Cancer Center | Wausau | Wisconsin |
United States | Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan |
United States | UHHS-Westlake Medical Center | Westlake | Ohio |
United States | Diagnostic and Treatment Center | Weston | Wisconsin |
United States | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania |
United States | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
NRG Oncology | National Cancer Institute (NCI) |
United States, Canada, India, Japan, Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) | Kaplan-Meier method will be used to calculate the PFS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in PFS between the two arms (Peto 1972). | From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years. | |
Secondary | Overall Survival (OS) | Kaplan-Meier method will be used to calculate the OS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in OS between the two arms (Peto 1972). Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates. | From randomization to death due to any cause, assessed up to 10 years | |
Secondary | 5 Year Overall Survival (OS) | Will be calculated based on the Kaplan-Meier curve. | At 5 years after randomization | |
Secondary | Disease-Specific Survival (DSS) | Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk (Gray 1988). Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates (Fine 1999). | From randomization to disease-related death, assessed up to 10 years | |
Secondary | 3 Year Disease-Specific Survival (DSS) | Will be calculated using the cumulative incidence function for each arm. | At 3 years after randomization | |
Secondary | 5 Year Disease-Specific Survival (DSS) | Will be calculated using the cumulative incidence function for each arm. | At 5 years after randomization | |
Secondary | 3 Year Progression-Free Survival (PFS) | Will be calculated based on the Kaplan-Meier curve. | From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years after randomization. | |
Secondary | 5 Year Progression-Free Survival (PFS) | Will be calculated based on the Kaplan-Meier curve. | From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years after randomization. | |
Secondary | Neurocognitive Function (NCF) | Longitudinal analysis will be performed to compare NCF over time between the 2 arms, using the NCF Clinical Trial Battery (CTB) composite score. Early change from baseline in CTB composite score will be evaluated and compared between the 2 arms using 2-sample t tests. | Baseline up to 60 months after randomization | |
Secondary | Patient Reported Outcomes (PRO) as assessed by MDASI-BT | Longitudinal analysis will be performed to compare symptom burden over time between the 2 arms, using the MDASI-BT. Early change from baseline in symptom burden will be evaluated and compared between the 2 arms using 2-sample t tests. | Baseline up to 60 months after randomization | |
Secondary | Assessment of pHH3 mitotic index | The Kaplan-Meier method will be used to estimate the PFS and OS rates by pHH3 category. The HRs on the effect of pHH3 on PFS and OS, respectively will be calculated using the Cox proportional hazard model and will be tested using the log-rank test. Multivariate analyses will be conducted with patient pretreatment characteristics, such as age and Simpson resection grade, included as covariates. | Up to 10 years after randomization | |
Secondary | Incidence of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4 (exclusive of alopecia) | The number of adverse events will be measured using the CTCAE, version 4 | Up to 3 years after randomization |
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