Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
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.
PRIMARY OBJECTIVE:
I. To determine the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.
SECONDARY OBJECTIVES:
I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Assessment of pHH3 mitotic index and its correlation with progression-free survival (PFS) and OS.
IX. Validation of the prognostic value of a 34-gene expression biomarker. X. Validation of the predictive value of a 34-gene expression biomarker in predicting the benefit of radiotherapy.
XI. Tissue and specimen collection for future translational research.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo observation. Additionally, patients undergo magnetic resonance imaging (MRI) and blood collection throughout the study.
ARM II: Patients undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.
After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.
Inclusion Criteria:
Exclusion Criteria:
Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)
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:
Birmingham, Alabama 35233, United States
Tucson, Arizona 85704, United States
Auburn, California 95603, United States
Los Angeles, California 90033, United States
Los Angeles, California 90033, United States
Orange, California 92868, United States
Rancho Cordova, California 95670, United States
Roseville, California 95661, United States
Roseville, California 95678, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Newark, Delaware 19718, United States
Seaford, Delaware 19973, United States
Coral Gables, Florida 33146, United States
Deerfield Beach, Florida 33442, United States
Hollywood, Florida 33021, United States
Miami, Florida 33136, United States
Plantation, Florida 33324, United States
Evanston, Illinois 60201, United States
Glenview, Illinois 60026, United States
Highland Park, Illinois 60035, United States
Indianapolis, Indiana 46202, United States
Iowa City, Iowa 52242, United States
Overland Park, Kansas 66210, United States
Lexington, Kentucky 40536, United States
Louisville, Kentucky 40202, United States
Shreveport, Louisiana 71103, United States
Baltimore, Maryland 21201, United States
Ann Arbor, Michigan 48106, United States
Ann Arbor, Michigan 48109, United States
Clinton Township, Michigan 48038, United States
Jackson, Mississippi 39216, United States
City of Saint Peters, Missouri 63376, United States
Columbia, Missouri 65212, United States
Lebanon, New Hampshire 03756, United States
Basking Ridge, New Jersey 07920, United States
Somerset, New Jersey 08873, United States
Somerville, New Jersey 08876, United States
Flushing, New York 11355, United States
New York, New York 10032, United States
Chapel Hill, North Carolina 27599, United States
Portland, Oregon 97210, United States
Bethlehem, Pennsylvania 18015, United States
Chadds Ford, Pennsylvania 19317, United States
Philadelphia, Pennsylvania 19107, United States
Wilkes-Barre, Pennsylvania 18711, United States
Boiling Springs, South Carolina 29316, United States
Charleston, South Carolina 29425, United States
Greenville, South Carolina 29605, United States
Greenville, South Carolina 29615, United States
Greer, South Carolina 29650, United States
Seneca, South Carolina 29672, United States
Nashville, Tennessee 37232, United States
San Antonio, Texas 78229, United States
American Fork, Utah 84003, United States
Seattle, Washington 98195, United States
Madison, Wisconsin 53718, United States
Madison, Wisconsin 53792, United States
Stevens Point, Wisconsin 54482, United States
Montreal, Quebec H3H 2R9, Canada
Shiwa-gun, Iwate 028-3695, Japan
Mitaka-shi, Tokyo 181-8611, Japan
Roster@nrgoncology.org412-339-5294
Shinjuku-ku, Tokyo 160-8582, Japan
03 5363-3848
clinical.trials@kp.org800-398-3996
clinicalresearch@sutterhealth.org
clinical.trials@kp.org800-398-3996
877-642-4691
clinical.trials@kp.org800-398-3996
clinicalresearch@sutterhealth.org
Kpoct@kp.org877-642-4691
clinical.trials@kp.org800-398-3996
ucstudy@uci.edu877-827-8839
Kpoct@kp.org877-642-4691
Kpoct@kp.org877-642-4691
clinicalresearch@sutterhealth.org
Kpoct@kp.org877-642-4691
clinicalresearch@sutterhealth.org
Kpoct@kp.org877-642-4691
clinicalresearch@sutterhealth.org
Kpoct@kp.org877-642-4691
Kpoct@kp.org877-642-4691
clinicalresearch@sutterhealth.org
860-545-5363
canceranswers@yale.edu203-785-5702
305-243-2647
305-243-2647
kginnity@med.miami.edu
OHR@mhs.net954-265-1847
305-243-2647
954-265-4325
305-243-2647
404-778-1868
allyson.anderson@emory.edu404-251-2854
ORS@piedmont.org404-425-7943
404-778-1868
404-851-7115
Roster@nrgoncology.org412-339-5294
ors@piedmont.org
404-425-1800
808-545-8548
cancer@northwestern.edu312-695-1301
Cancer_Studies@rush.edu312-226-2371
312-355-3046
847-570-2109
Donald.Smith3@nm.org630-352-5360
847-570-2109
847-570-2109
708-226-4357
Donald.Smith3@nm.org630-352-5360
515-241-6727
502-562-3429
ctoinfo@louisville.edu502-852-2755
Roster@nrgoncology.org412-339-5294
clinicalresearch@mainehealth.org207-396-8670
207-459-1600
clinicalresearch@mainehealth.org207-396-8670
ContactUsCancerCenter@TuftsMedicalCenter.org617-636-5000
CTOResearch@hfhs.org313-916-3721
CTOResearch@hfhs.org313-916-3721
crcwm-regulatory@crcwm.org616-391-1230
CTOResearch@hfhs.org313-916-3721
crcwm-regulatory@crcwm.org616-391-1230
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
855-776-0015
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
info@siteman.wustl.edu800-600-3606
info@siteman.wustl.edu800-600-3606
info@siteman.wustl.edu800-600-3606
info@siteman.wustl.edu800-600-3606
mccinfo@mtcancer.org406-969-6060
cancer.research.nurse@dartmouth.edu800-639-6918
201-894-3456
732-776-4240
732-235-7356
clinicaltrials@capitalhealth.org609-394-4130
HSC-ClinicalTrialInfo@salud.unm.edu505-925-0348
Adg9003@nyp.org718-780-3677
CTUReferral@UHhospitals.org800-641-2422
TaussigResearch@ccf.org866-223-8100
Jamesline@osumc.edu800-293-5066
CTUReferral@UHhospitals.org800-641-2422
PCIOncResearch@promedica.org419-824-1842
HemonCCTrials@geisinger.edu570-271-5251
HemonCCTrials@geisinger.edu570-374-8555
HemonCCTrials@geisinger.edu717-242-7703
HemonCCTrials@geisinger.edu800-275-6401
HemonCCTrials@geisinger.edu570-271-5251
canceranswerline@UTSouthwestern.edu214-648-7097
officeofresearch@imail.org801-855-4100
officeofresearch@imail.org435-716-6400
officeofresearch@imail.org801-507-3950
officeofresearch@imail.org801-387-7426
officeofresearch@imail.org801-357-7965
officeofresearch@imail.org801-507-3950
officeofresearch@imail.org801-408-1347
cancer.research.nurse@hitchcock.org800-639-6918
Juli.Alford@aspirus.org715-623-9869
oncology.clinical.trials@marshfieldresearch.org800-782-8581
clinicaltrials@cancer.wisc.edu800-622-8922
clinicaltrials@cancer.wisc.edu800-622-8922
oncology.clinical.trials@marshfieldresearch.org800-782-8581
262-257-5100
414-805-3666
oncology.clinical.trials@marshfieldresearch.org800-782-8581
414-805-0505
oncology.clinical.trials@marshfieldresearch.org800-782-8581
Beth.Knetter@aspirus.org715-847-2353
oncology.clinical.trials@marshfieldresearch.org800-782-8581
Chanda.miller@phci.org262-928-5539
877-405-6866
oncology.clinical.trials@marshfieldresearch.org888-799-3989
715-422-7718
905-387-9495
clinical.trials@uhn.on.ca416-946-4501
hassi@med.hokudai.ac.jp
82-424-6042
81-49-276-2028
www-admin@ncc.go.jp81-3-3542-2511