Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03180268 : Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
PhaseN/A
AgesMin: 18 Years Max: N/A
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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT03180268      |      Link to official Clinicaltrials.gov listing
Locations
Regina, Saskatchewan
Canada

Facility: Allan Blair Cancer Centre
Investigator: Michelle J. Ferguson
Contact: Michelle J. Ferguson Phone: 306-766-2213
Email not avaialable

Phoenix, Arizona
Facility: Saint Joseph's Hospital and Medical Center
Investigator: C. L. Rogers
Contact: C. L. Rogers Phone: 412-339-5294
Click HERE to send email to this center

Los Angeles, California
Facility: Kaiser Permanente Los Angeles Medical Center
Investigator: Michael R. Girvigian
Contact: Michael R. Girvigian Phone: 626-564-3455
Email not avaialable

Los Angeles, California
Facility: Los Angeles County-USC Medical Center
Investigator: Eric L. Chang
Contact: Eric L. Chang Phone: 323-865-0451
Email not avaialable

Los Angeles, California
Facility: USC / Norris Comprehensive Cancer Center
Investigator: Eric L. Chang
Contact: Eric L. Chang Phone: 323-865-0451
Email not avaialable

Oakland, California
Facility: Kaiser Permanente Oakland-Broadway
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 510-891-3400
Email not avaialable

Orange, California
Facility: UC Irvine Health/Chao Family Comprehensive Cancer Center
Investigator: Xiao-Tang Kong
Contact: Xiao-Tang Kong Phone: 877-827-8839
Click HERE to send email to this center

Palo Alto, California
Facility: Stanford Cancer Institute Palo Alto
Investigator: Scott G. Soltys
Contact: Scott G. Soltys Phone: 650-498-7061
Click HERE to send email to this center

Rancho Cordova, California
Facility: Kaiser Permanente-Rancho Cordova Cancer Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 510-891-3400
Email not avaialable

Roseville, California
Facility: The Permanente Medical Group-Roseville Radiation Oncology
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 510-891-3400
Email not avaialable

Sacramento, California
Facility: South Sacramento Cancer Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 916-683-9616
Email not avaialable

Santa Clara, California
Facility: Kaiser Permanente Medical Center - Santa Clara
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 510-891-3400
Email not avaialable

South San Francisco, California
Facility: Kaiser Permanente Cancer Treatment Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 510-891-3400
Email not avaialable

Boca Raton, Florida
Facility: Boca Raton Regional Hospital
Investigator: Gregg H. Goldin
Contact: Gregg H. Goldin Phone: 561-955-4800
Email not avaialable

Deerfield Beach, Florida
Facility: UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Investigator: Eric A. Mellon
Contact: Eric A. Mellon Phone: 305-243-2647
Email not avaialable

Miami, Florida
Facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
Investigator: Eric A. Mellon
Contact: Eric A. Mellon Phone: 305-243-2647
Email not avaialable

Atlanta, Georgia
Facility: Emory University Hospital/Winship Cancer Institute
Investigator: Bree R. Eaton
Contact: Bree R. Eaton Phone: 404-778-1868
Email not avaialable

Atlanta, Georgia
Facility: Emory Saint Joseph's Hospital
Investigator: Bree R. Eaton
Contact: Bree R. Eaton Phone: 412-339-5294
Click HERE to send email to this center

Honolulu, Hawaii
Facility: Queen's Medical Center
Investigator: Richard Y. Lee
Contact: Richard Y. Lee Phone: 412-339-5294
Click HERE to send email to this center

Honolulu, Hawaii
Facility: The Cancer Center of Hawaii-Liliha
Investigator: Richard Y. Lee
Contact: Richard Y. Lee Phone: 808-547-6011
Email not avaialable

Chicago, Illinois
Facility: Northwestern University
Investigator: Sean Sachdev
Contact: Sean Sachdev Phone: 312-695-1301
Click HERE to send email to this center

Decatur, Illinois
Facility: Decatur Memorial Hospital
Investigator: James L. Wade
Contact: James L. Wade Phone: 217-876-6601
Email not avaialable

Geneva, Illinois
Facility: Northwestern Medicine Cancer Center Delnor
Investigator: Vinai Gondi
Contact: Vinai Gondi Phone: 630-315-1918
Click HERE to send email to this center

Warrenville, Illinois
Facility: Northwestern Medicine Cancer Center Warrenville
Investigator: Vinai Gondi
Contact: Vinai Gondi Phone: 630-315-1918
Click HERE to send email to this center

Scarborough, Maine
Facility: Maine Medical Center- Scarborough Campus
Investigator: Matthew D. Cheney
Contact: Matthew D. Cheney Phone: 207-396-8090
Click HERE to send email to this center

Ann Arbor, Michigan
Facility: University of Michigan Comprehensive Cancer Center
Investigator: Michelle M. Kim
Contact: Michelle M. Kim Phone: 800-865-1125
Email not avaialable

Creve Coeur, Missouri
Facility: Siteman Cancer Center at West County Hospital
Investigator: Christina I. Tsien
Contact: Christina I. Tsien Phone: 800-600-3606
Click HERE to send email to this center

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Christina I. Tsien
Contact: Christina I. Tsien Phone: 800-600-3606
Click HERE to send email to this center

Saint Louis, Missouri
Facility: Siteman Cancer Center-South County
Investigator: Christina I. Tsien
Contact: Christina I. Tsien Phone: 800-600-3606
Click HERE to send email to this center

Saint Peters, Missouri
Facility: Siteman Cancer Center at Saint Peters Hospital
Investigator: Christina I. Tsien
Contact: Christina I. Tsien Phone: 800-600-3606
Click HERE to send email to this center

Great Falls, Montana
Facility: Benefis Healthcare- Sletten Cancer Institute
Investigator: Benjamin T. Marchello
Contact: Benjamin T. Marchello Phone: 406-969-6060
Click HERE to send email to this center

Albuquerque, New Mexico
Facility: University of New Mexico Cancer Center
Investigator: Benny J. Liem
Contact: Benny J. Liem Phone: 505-925-0366
Click HERE to send email to this center

Sylvania, Ohio
Facility: Flower Hospital
Investigator: Abhijit B. Saste
Contact: Abhijit B. Saste Phone: 419-824-1842
Email not avaialable

Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Terence S. Herman
Contact: Terence S. Herman Phone: 405-271-8777
Click HERE to send email to this center

Portland, Oregon
Facility: Legacy Good Samaritan Hospital and Medical Center
Investigator: Andrew Y. Kee
Contact: Andrew Y. Kee Phone: 800-220-4937
Click HERE to send email to this center

Philadelphia, Pennsylvania
Facility: NRG Oncology
Investigator: C. L. Rogers
Contact: C. L. Rogers Phone: 804-628-1939
Email not avaialable

Philadelphia, Pennsylvania
Facility: Thomas Jefferson University Hospital
Investigator: Wenyin Shi
Contact: Wenyin Shi Phone: 215-955-6084
Email not avaialable

Charleston, South Carolina
Facility: Medical University of South Carolina
Investigator: Scott M. Lindhorst
Contact: Scott M. Lindhorst Phone: 843-792-9321
Email not avaialable

Greenville, South Carolina
Facility: Greenville Health System Cancer Institute-Faris
Investigator: David L. Grisell
Contact: David L. Grisell Phone: 864-241-6251
Email not avaialable

Greenville, South Carolina
Facility: Greenville Health System Cancer Institute-Eastside
Investigator: David L. Grisell
Contact: David L. Grisell Phone: 864-679-3966
Email not avaialable

Seneca, South Carolina
Facility: Greenville Health System Cancer Institute-Seneca
Investigator: David L. Grisell
Contact: David L. Grisell Phone: 864-241-6251
Email not avaialable

Houston, Texas
Facility: M D Anderson Cancer Center
Investigator: Debra N. Yeboa
Contact: Debra N. Yeboa Phone: 713-792-3245
Email not avaialable

Seattle, Washington
Facility: University of Washington Medical Center
Investigator: Lia M. Halasz
Contact: Lia M. Halasz Phone: 206-616-8289
Email not avaialable

Madison, Wisconsin
Facility: University of Wisconsin Hospital and Clinics
Investigator: Steven P. Howard
Contact: Steven P. Howard Phone: 800-622-8922
Email not avaialable




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