Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
Purpose
This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma.
Conditions
- Glioblastoma
- Gliosarcoma
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- STEP 1 REGISTRATION: No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered) - STEP 1 REGISTRATION: Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the NYU Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be received by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be conveyed to NRG Oncology within 10 business days of receipt of tissue. Note: In the event of an additional tumor resection(s), tissue must be received within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis - STEP 1 REGISTRATION: Contrast-enhanced brain MRI after surgery - STEP 1 REGISTRATION: Willing to use highly effective method of contraception for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 6 months after completing treatment; this inclusion is necessary because the treatment in this study may be significantly teratogenic - STEP 1 REGISTRATION: The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information - STEP 2 REGISTRATION: Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review - STEP 2 REGISTRATION: MGMT promoter with methylation confirmed by central pathology review (See Section 10 for details). Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or unmethylated MGMT promoter are excluded. - STEP 2 REGISTRATION: IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2.) - STEP 2 REGISTRATION: History/physical examination within 28 days prior to Step 2 registration - STEP 2 REGISTRATION: Karnofsky performance status (KPS) >= 70 within 28 days prior to Step 2 registration - STEP 2 REGISTRATION: Neurologic function assessment within 28 days prior to Step 2 registration - STEP 2 REGISTRATION: Age 18-70 years Adequate hematologic, renal, and hepatic function within 14 days prior to STEP 2 REGISTRATION defined as follows: - STEP 2 REGISTRATION: Hemoglobin >= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable) - STEP 2 REGISTRATION: Leukocytes >= 2,000/mm^3 - STEP 2 REGISTRATION: Absolute neutrophil count >= 1,500/mm^3 - STEP 2 REGISTRATION: Platelets >= 100,000/mm^3 - STEP 2 REGISTRATION: Total bilirubin =< 1.5 x institutional/lab upper limit of normal (ULN) - STEP 2 REGISTRATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x ULN - STEP 2 REGISTRATION: Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN - STEP 2 REGISTRATION: Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula - STEP 2 REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B) - STEP 2 REGISTRATION: For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Note: Known positive test for hepatitis C virus ribonucleic acid (HCV ribonucleic acid [RNA]) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy - STEP 2 REGISTRATION: Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to step 2 registration are eligible for this trial. Testing is not required for entry into protocol - STEP 2 REGISTRATION: Negative serum or urine pregnancy test (in persons of childbearing potential) within 14 days prior to Step 2 registration - Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
Exclusion Criteria
- STEP 2 REGISTRATION: Prior therapy for tumor, except for resection or prior laser interstitial thermal therapy (LITT). For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is Gliadel wafer, radiotherapy, radiosurgery, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery - Note: 5-aminolevulinic acid (ALA)-mediated fluorescent guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent. Prior laser interstitial thermal therapy (LITT) is allowed. - STEP 2 REGISTRATION: Current or planned treatment with any other investigational agents for the study cancer - STEP 2 REGISTRATION: Definitive clinical or radiologic evidence of metastatic disease outside the brain - STEP 2 REGISTRATION: Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years - STEP 2 REGISTRATION: Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields - STEP 2 REGISTRATION: Pregnancy and individuals unwilling to discontinue nursing due to the potential teratogenic effects and potential risk for adverse events in nursing infants - STEP 2 REGISTRATION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or lomustine - STEP 2 REGISTRATION: History of pulmonary fibrosis - STEP 2 REGISTRATION: Uncontrolled intercurrent illness including, but not limited to: - Ongoing or active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatment - Symptomatic congestive heart failure, defined as New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification) - Unstable angina pectoris within 6 months prior to Step 2 registration - Uncontrolled cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements - STEP 2 REGISTRATION: No evidence of diffuse leptomeningeal disease that requires whole brain irradiation.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (radiation therapy, temozolomide) |
Patients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. |
|
|
Experimental ARM II (radiation therapy, temozolomide, lomustine) |
Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Kaiser Permanente-Anaheim
Anaheim, California 92806
Anaheim, California 92806
Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
Antioch, California 94531
Sutter Auburn Faith Hospital
Auburn, California 95602
Auburn, California 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
Auburn, California 95603
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Berkeley, California 94704
Mercy Cancer Center �� Carmichael
Carmichael, California 95608
Carmichael, California 95608
Mercy San Juan Medical Center
Carmichael, California 95608
Carmichael, California 95608
John Muir Medical Center-Concord Campus
Concord, California 94520
Concord, California 94520
Contact:
Site Public Contact
925-674-2580
Site Public Contact
925-674-2580
Kaiser Permanente Dublin
Dublin, California 94568
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Elk Grove, California 95758
Kaiser Permanente-Fremont
Fremont, California 94538
Fremont, California 94538
Fresno Cancer Center
Fresno, California 93720
Fresno, California 93720
Kaiser Permanente-Fresno
Fresno, California 93720
Fresno, California 93720
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Kaiser Permanente-Modesto
Modesto, California 95356
Modesto, California 95356
Kaiser Permanente Oakland-Broadway
Oakland, California 94611
Oakland, California 94611
Kaiser Permanente-Oakland
Oakland, California 94611
Oakland, California 94611
Kaiser Permanente-Ontario
Ontario, California 91761
Ontario, California 91761
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Orange, California 92868
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
Rancho Cordova, California 95670
Kaiser Permanente- Marshall Medical Offices
Redwood City, California 94063
Redwood City, California 94063
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Richmond
Richmond, California 94801
Richmond, California 94801
Mercy Cancer Center - Rocklin
Rocklin, California 95765
Rocklin, California 95765
Rohnert Park Cancer Center
Rohnert Park, California 94928
Rohnert Park, California 94928
Kaiser Permanente-Roseville
Roseville, California 95661
Roseville, California 95661
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
Roseville, California 95661
Sutter Roseville Medical Center
Roseville, California 95661
Roseville, California 95661
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
Roseville, California 95678
Kaiser Permanente Downtown Commons
Sacramento, California 95814
Sacramento, California 95814
Mercy Cancer Center - Sacramento
Sacramento, California 95816
Sacramento, California 95816
Sutter Medical Center Sacramento
Sacramento, California 95816
Sacramento, California 95816
Kaiser Permanente-South Sacramento
Sacramento, California 95823
Sacramento, California 95823
South Sacramento Cancer Center
Sacramento, California 95823
Sacramento, California 95823
Kaiser Permanente-San Diego Zion
San Diego, California 92120
San Diego, California 92120
Kaiser Permanente-San Francisco
San Francisco, California 94115
San Francisco, California 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
San Jose, California 95119
Kaiser Permanente San Leandro
San Leandro, California 94577
San Leandro, California 94577
Kaiser San Rafael-Gallinas
San Rafael, California 94903
San Rafael, California 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Santa Clara, California 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Santa Rosa, California 95403
Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
South San Francisco, California 94080
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
South San Francisco, California 94080
Kaiser Permanente-Stockton
Stockton, California 95210
Stockton, California 95210
Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
Vacaville, California 95688
Kaiser Permanente-Vallejo
Vallejo, California 94589
Vallejo, California 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Walnut Creek, California 94596
John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598
Walnut Creek, California 94598
Contact:
Site Public Contact
925-941-4246
Site Public Contact
925-941-4246
Woodland Memorial Hospital
Woodland, California 95695
Woodland, California 95695
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406
Site Public Contact
719-365-2406
Memorial Hospital North
Colorado Springs, Colorado 80920
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700
Site Public Contact
719-364-6700
Poudre Valley Hospital
Fort Collins, Colorado 80524
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150
Site Public Contact
970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
SCL Health Cancer Centers of Colorado - Lutheran Medical Center
Golden, Colorado 80401
Golden, Colorado 80401
UCHealth Greeley Hospital
Greeley, Colorado 80631
Greeley, Colorado 80631
Littleton Adventist Hospital
Littleton, Colorado 80122
Littleton, Colorado 80122
Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083
Site Public Contact
970-203-7083
Parker Adventist Hospital
Parker, Colorado 80138
Parker, Colorado 80138
Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Contact:
Site Public Contact
904-202-7468
Site Public Contact
904-202-7468
Miami Cancer Institute
Miami, Florida 33176
Miami, Florida 33176
Contact:
Site Public Contact
786-596-2000
Site Public Contact
786-596-2000
Augusta University Medical Center
Augusta, Georgia 30912
Augusta, Georgia 30912
Rush - Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847
Site Public Contact
847-842-4847
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
University of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Crystal Lake, Illinois 60014
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Advocate Sherman Hospital
Elgin, Illinois 60123
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907
Site Public Contact
847-429-2907
Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995
Site Public Contact
708-799-9995
AMG Libertyville - Oncology
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622
Site Public Contact
800-323-8622
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621
Site Public Contact
847-384-3621
Memorial Hospital East
Shiloh, Illinois 62269
Shiloh, Illinois 62269
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
The Carle Foundation Hospital
Urbana, Illinois 61801
Urbana, Illinois 61801
Community Cancer Center South
Indianapolis, Indiana 46227
Indianapolis, Indiana 46227
Community Cancer Center North
Indianapolis, Indiana 46256
Indianapolis, Indiana 46256
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
Mercy Hospital
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673
Site Public Contact
319-365-4673
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690
Site Public Contact
319-363-2690
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Clive, Iowa 50325
Greater Regional Medical Center
Creston, Iowa 50801
Creston, Iowa 50801
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Mission Cancer and Blood - Laurel
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Siouxland Regional Cancer Center
Sioux City, Iowa 51101
Sioux City, Iowa 51101
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
University of Kansas Cancer Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Overland Park, Kansas 66211
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379
Site Public Contact
859-257-3379
Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005
Site Public Contact
800-987-3005
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823
Site Public Contact
800-888-8823
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300
Site Public Contact
443-546-1300
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100
Site Public Contact
410-553-8100
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Saint Joseph Mercy Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Ascension Saint John Hospital
Detroit, Michigan 48236
Detroit, Michigan 48236
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Borgess Medical Center
Kalamazoo, Michigan 49048
Kalamazoo, Michigan 49048
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
Macomb, Michigan 48044
21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Warren, Michigan 48093
University of Michigan Health - West
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Robbinsdale, Minnesota 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Lakeview Hospital
Stillwater, Minnesota 55082
Stillwater, Minnesota 55082
Ridgeview Medical Center
Waconia, Minnesota 55387
Waconia, Minnesota 55387
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Research Medical Center
Kansas City, Missouri 64132
Kansas City, Missouri 64132
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Saint Louis, Missouri 63129
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Saint Peters, Missouri 63376
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Saint Barnabas Medical Center
Livingston, New Jersey 07039
Livingston, New Jersey 07039
Jersey Shore Medical Center
Neptune, New Jersey 07753
Neptune, New Jersey 07753
Contact:
Site Public Contact
732-776-4240
Site Public Contact
732-776-4240
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Sands Cancer Center
Canandaigua, New York 14424
Canandaigua, New York 14424
Contact:
Site Public Contact
585-396-6161
Site Public Contact
585-396-6161
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York 14437
Dansville, New York 14437
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
New York, New York 10032
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Cleveland Clinic Akron General
Akron, Ohio 44307
Akron, Ohio 44307
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Centerville, Ohio 45459
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
Adena Regional Medical Center
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
MetroHealth Medical Center
Cleveland, Ohio 44109
Cleveland, Ohio 44109
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Dayton Blood and Cancer Center
Dayton, Ohio 45409
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320
Site Public Contact
937-276-8320
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Franklin, Ohio 45005-1066
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515
Site Public Contact
937-569-7515
ProMedica Flower Hospital
Sylvania, Ohio 43560
Sylvania, Ohio 43560
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio 43606
Toledo, Ohio 43606
Upper Valley Medical Center
Troy, Ohio 45373
Troy, Ohio 45373
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
Gresham, Oregon 97030
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Portland, Oregon 97210
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Kaiser Permanente Northwest
Portland, Oregon 97227
Portland, Oregon 97227
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742
Site Public Contact
503-413-1742
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Farrell, Pennsylvania 16121
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334
Site Public Contact
412-621-2334
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454
Site Public Contact
412-367-6454
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Pottsville, Pennsylvania 17901
Reading Hospital
West Reading, Pennsylvania 19611
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323
Site Public Contact
610-988-9323
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Avera Cancer Institute
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Avera Cancer Institute at Yankton
Yankton, South Dakota 57078
Yankton, South Dakota 57078
Parkland Memorial Hospital
Dallas, Texas 75235
Dallas, Texas 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Dallas, Texas 75390
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
Berlin, Vermont 05602
Contact:
Site Public Contact
802-225-5400
Site Public Contact
802-225-5400
University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
University of Vermont and State Agricultural College
Burlington, Vermont 05405
Burlington, Vermont 05405
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont 05819
Saint Johnsbury, Vermont 05819
Inova Alexandria Hospital
Alexandria, Virginia 22304
Alexandria, Virginia 22304
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Inova Fair Oaks Hospital
Fairfax, Virginia 22033
Fairfax, Virginia 22033
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
Mechanicsville, Virginia 23116
Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Midlothian, Virginia 23114
Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
Richmond, Virginia 23226
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
Richmond, Virginia 23230
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Richmond, Virginia 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
Vancouver, Washington 98684
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Antigo, Wisconsin 54409
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Germantown, Wisconsin 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin 53038
Johnson Creek, Wisconsin 53038
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
Site Public Contact
800-622-8922
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53233
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Mukwonago, Wisconsin 53149
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878
Site Public Contact
262-928-7878
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Racine, Wisconsin 53406
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin 54501
Rhinelander, Wisconsin 54501
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54481
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Summit, Wisconsin 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Two Rivers, Wisconsin 54241
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866
Site Public Contact
877-405-6866
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
West Allis, Wisconsin 53227
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718
Site Public Contact
715-422-7718
More Details
- NCT ID
- NCT05095376
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVE: I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs overall survival (OS) versus (vs.) standard chemoradiotherapy with temozolomide in patients with newly diagnosed glioblastoma (GBM) with MGMT promoter methylation. SECONDARY OBJECTIVES: I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs progression-free survival (PFS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation. II. To compare the two different chemotherapy regimens on patient-reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM with MGMT promoter methylation. III. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) is associated with inferior short-term change in patient reported outcomes (PROs) as measured by MDASI-BT vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation. IV. To assess toxicity in the two different chemotherapy regimens. EXPLORATORY OBJECTIVES: I. To assess the association between absolute lymphocyte counts and outcomes. II. To assess the association between CD4+ lymphocyte counts and outcomes. III. To compare the two different chemotherapy regimens in terms of long-term PROs as measured by MDASI-BT at years 1 and 2. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo radiation therapy 5 days per week and receive temozolomide orally (PO) once daily (QD) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for year 1, every 4 months for year 2, and then every 6 months thereafter.