Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

• ClinicalTrials.gov Identifier: NCT02179086
• Recruitment Status: Recruiting
• First Posted: July 1, 2014
• Last Update Posted: April 21, 2020
• Sponsor: NRG Oncology
• Collaborators: National Cancer Institute (NCI); Radiation Therapy Oncology Group
• Information provided by (Responsible Party): NRG Oncology

Study Description

Brief Summary:

This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.

Condition or disease	Intervention/treatment	Phase
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma	Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy; Radiation: photon beam radiation therapy; Radiation: proton beam radiation therapy; Drug: temozolomide; Other: laboratory biomarker analysis	Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if dose-escalated and -intensified photon IMRT or proton beam therapy (using a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and adjuvant temozolomide improves overall survival, as compared to standard-dose photon irradiation with concomitant and adjuvant temozolomide.

SECONDARY OBJECTIVES:

I. To indirectly compare dose-escalated and -intensified photon IMRT to dose-escalated and -intensified proton beam therapy in terms of overall survival.

II. To indirectly compare and record toxicities of dose-escalated and -intensified photon IMRT versus dose-escalated and -intensified proton beam therapy and directly compare the toxicities of these approaches versus standard-dose photon irradiation on the backbone of concomitant and adjuvant temozolomide.

III. To indirectly determine if dose-escalated and -intensified proton beam therapy with concomitant and adjuvant temozolomide improves perceived cognitive symptom severity, as compared to dose-escalated and -intensified photon IMRT, and to directly compare symptom burden with these approaches versus standard-dose photon irradiation on the backbone of concomitant and adjuvant temozolomide.

IV. To indirectly determine if dose-escalated and -intensified proton beam therapy with concomitant and adjuvant temozolomide improves neurocognitive function, as compared to dose-escalated and -intensified photon IMRT, and to directly compare neurocognitive function with these approaches versus standard-dose photon irradiation on the backbone of concomitant and adjuvant temozolomide.

TERTIARY OBJECTIVES:

I. Tissue banking for future translational science projects that will be determined based on the state of the science at the time the primary endpoint is reported and will be submitted to National Cancer Institute (NCI) for review and approval.

II. To prospectively compare cluster of differentiation (CD)4 lymphopenia between dose-escalated and intensified proton beam therapy, dose-escalated and -intensified photon IMRT, and standard-dose photon irradiation.

III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.

• To establish feasibility and clinical relevancy of quality assurance guidelines.
• To evaluate efficacy of quality assurance tools.

OUTLINE: Patients are assigned to 1 of 2 groups depending on enrolling institution. Within each group, patients will be randomized 1:2 in favor of the experimental arms.

GROUP I (PHOTON IMRT CENTERS): Patients are randomized to 1 of 2 treatment arms.

ARM A1: Patients undergo standard-dose photon irradiation using 3-dimensional conformal radiation therapy (3D-CRT) or IMRT once daily (QD), 5 days a week for 23 fractions plus a boost of 7 additional fractions.

ARM B: Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions.

GROUP II (PROTON CENTERS): Patients are randomized to 1 of 2 treatment arms.

ARM A2: Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1.

ARM C: Patients undergo dose-escalated and -intensified proton beam radiation therapy QD, 5 days a week for a total of 30 fractions.

In all treatment arms, patients receive temozolomide orally (PO) QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 606 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
• Actual Study Start Date: October 27, 2014
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: May 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm A1 (control); Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT QD, 5 days a week for 23 fractions plus a boost of 7 additional fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Radiation: 3-dimensional conformal radiation therapy; Undergo standard-dose 3D-CRT; Other Names: 3D conformal radiation therapy; 3D-CRT; Radiation: intensity-modulated radiation therapy; Undergo standard-dose IMRT; Other Name: IMRT; Drug: temozolomide; Given PO; Other Names: SCH 52365; Temodal; Temodar; TMZ; Other: laboratory biomarker analysis; Correlative studies
Experimental: Arm B (photon IMRT); Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Radiation: photon beam radiation therapy; Undergo dose-escalated and -intensified photon IMRT; Radiation: intensity-modulated radiation therapy; Undergo dose-escalated and -intensified photon IMRT; Other Name: IMRT; Drug: temozolomide; Given PO; Other Names: SCH 52365; Temodal; Temodar; TMZ; Other: laboratory biomarker analysis; Correlative studies
Active Comparator: Arm A2 (control); Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Radiation: 3-dimensional conformal radiation therapy; Undergo standard-dose 3D-CRT; Other Names: 3D conformal radiation therapy; 3D-CRT; Radiation: intensity-modulated radiation therapy; Undergo standard-dose IMRT; Other Name: IMRT; Drug: temozolomide; Given PO; Other Names: SCH 52365; Temodal; Temodar; TMZ; Other: laboratory biomarker analysis; Correlative studies
Experimental: Arm C (proton beam radiation therapy); Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Radiation: proton beam radiation therapy; Undergo dose-escalated and -intensified proton beam radiation therapy; Drug: temozolomide; Given PO; Other Names: SCH 52365; Temodal; Temodar; TMZ; Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures :

1. Overall survival (OS) compared between dose-escalated and -intensified photon IMRT or proton beam therapy with concomitant and adjuvant temozolomide and the standard-dose photon irradiation with concomitant and adjuvant temozolomide [ Time Frame: Date of randomization to the date of death due to any cause, assessed up to 5 years ]
   OS rate will be estimated using the Kaplan-Meier method, and differences between treatment arms will be tested in a stratified log-rank test, consistent with the stratified randomization. The OS rates by MGMT, recursive partitioning analysis (RPA) class and other prognostic factors will be estimated by Kaplan-Meier methods and compared using the log-rank test. Multivariate analyses with the Cox proportional hazard model for OS will be performed to assess the treatment effect adjusting for patient-specific risk factors.

Secondary Outcome Measures :

1. OS when compared between dose-escalated and -intensified photon IMRT to dose-escalated and -intensified proton beam therapy [ Time Frame: Date of randomization to the date of death, assessed up to 5 years ]
   If the instrumental variable assumptions hold, OS rate will be estimated using the Kaplan-Meier method, and differences between treatment arms will be tested in the log-rank test.
2. Progression-free survival (PFS) [ Time Frame: Date of randomization to the date of progression or death, assessed up to 5 years ]
   PFS rates will be estimated using the Kaplan-Meier method and comparisons between treatment arms will be made in the same manner as for OS.
3. Incidence of treatment-related toxicity, as measured by the Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 5 years ]
   Differences in observed severities of toxicities (grade 3+) between groups will be estimated using an exact binomial distribution together with 95% confidence interval. The difference between the 2 groups will be tested using a chi square test. If the instrumental variable assumptions hold the experimental arms will also be compared.
4. Change in perceived cognitive function, as measured by M.D. Anderson Symptom Inventory Brain Tumor [ Time Frame: Baseline to up to 60 weeks ]
   The change from baseline to each follow-up time point for the perceived cognitive symptom severity score will each be compared using a t-test with alpha=0.05, or Wilcoxon test if the data is not normally distributed, between treatment arms within each group. If the instrumental variable assumptions hold and the perceived cognitive function is significantly different within both groups, a test will be performed to compare between the 2 experimental arms.
5. Change in neurocognitive function, as measured by Hopkins' Verbal Learning Test-Revised, Trail Making Test Parts A and B, and Controlled Oral Word Association Test [ Time Frame: Baseline to up to 60 weeks ]
   The change from baseline to each follow-up time point for the perceived Clinical Trial Battery (CTB) composite score will each be compared using a t-test with alpha=0.05, or Wilcoxon test if the data is not normally distributed, between treatment arms within each group. If the instrumental variable assumptions hold and the CTB composite score is significantly different within both groups, a test will be performed to compare between the 2 experimental arms.
6. Change in CD4 lymphopenia count [ Time Frame: Baseline to up to 5 years ]
   The change from baseline to the completion of radiation will be compared between the control and experimental arms in each group using a t-test. If the instrumental variable assumptions hold, then it will be compared between the experimental arms. A repeated measures analysis, using a mixed effects model, will be used to assess the change of CD4 lymphopenia across time. CD4 count at 2 months after beginning therapy (dichotomized at 200) was shown to be prognostic of OS. This will be assessed here based on the CD4 count at the completion of chemoradiation which matches best to 2-months.
7. Use of magnetic resonance diffusion and perfusion imaging to differentiate between tumor progression and pseudo-progression [ Time Frame: Up to 5 years ]
   Retrospective analysis will be performed to evaluate and refine the method and the threshold cut-off point determined from our previous single institute data set to determine progression using the first one-third of the patient data collected in this trial. If the initial analysis supports our preliminary results with sufficient high sensitivity and specificity, e.g., 80% specificity and 90% sensitivity or higher, results will be validated using the remaining two-thirds of the imaging data.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• PRIOR TO STEP 1 REGISTRATION
• A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type allowed) of the brain must be performed postoperatively within 72 hours of resection; the enhancing tumor must have a maximal diameter of 5 cm; the tumor diameter will be the greatest diameter as measured on the contrast-enhanced postoperative MRI and will include residual disease and/or the postoperative surgical cavity as appropriate; for cases where residual disease or postoperative surgical cavity is NOT identifiable (e.g., polar glioblastomas [GBMs] where a polar lobectomy is performed), the patient will be excluded from the trial
• The GBM tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
• Patients must provide study-specific informed consent prior to step 1 registration
• PRIOR TO STEP 2 REGISTRATION
• Histologically proven diagnosis of glioblastoma (World Health Organization [WHO] grade IV) confirmed by central review prior to step 2 registration

• Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient quantity for analysis of O6-methylguanin-DNA-methyltransferase (MGMT) status

  • Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged to maximize the chances of eligibility; at least 1 cubic centimeter of tissue composed primarily of tumor must be present
  • Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy or cavitron ultrasonic suction aspirator (CUSA) technique are not allowed
• History/physical examination within 28 days prior to step 2 registration
• The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days prior to step 2 registration
• Documentation of steroid doses within 28 days prior to step 2 registration
• Karnofsky performance status >= 70 within 28 days prior to step 2 registration
• Age >= 18
• Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
• Platelets >= 100,000 cells/mm^3
• Hemoglobin >= 10.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
• Bilirubin =< 1.5 upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
• Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration

Exclusion Criteria:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
• Recurrent or multifocal malignant gliomas
• Any site of distant disease (for example, drop metastases from the GBM tumor site)
• Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)
• Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
• Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields

• Severe, active co-morbidity, defined as follows:

  • Unstable angina at step 2 registration
  • Transmural myocardial infarction within the last 6 months prior to step 2 registration
  • Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to step 2 registration
  • New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
  • Serious and inadequately controlled arrhythmia at step 2 registration
  • Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for surgical resection
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
  • Any other severe immunocompromised condition
  • Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
  • End-stage renal disease (ie, on dialysis or dialysis has been recommended)
  • Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
• Patents treated on any other therapeutic clinical protocols within 30 days prior to step 2 registration
• Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker, or severe claustrophobia)
• Postoperative tumor plus surgical bed size exceeds 5 cm in maximum diameter.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham Cancer Center; Active, not recruiting

Birmingham, Alabama, United States, 35233

United States, Arizona

Saint Joseph's Hospital and Medical Center; Suspended

Phoenix, Arizona, United States, 85013

Mayo Clinic Hospital; Recruiting

Phoenix, Arizona, United States, 85054

Contact: Site Public Contact 855-776-0015

Principal Investigator: Sujay A. Vora

Mayo Clinic in Arizona; Recruiting

Scottsdale, Arizona, United States, 85259

Contact: Site Public Contact 855-776-0015

Principal Investigator: Sujay A. Vora

Arizona Oncology Associates-West Orange Grove; Active, not recruiting

Tucson, Arizona, United States, 85704

Banner University Medical Center - Tucson; Suspended

Tucson, Arizona, United States, 85719

United States, Arkansas

University of Arkansas for Medical Sciences; Suspended

Little Rock, Arkansas, United States, 72205

United States, California

Sutter Cancer Centers Radiation Oncology Services-Auburn; Suspended

Auburn, California, United States, 95603

AIS Cancer Center at San Joaquin Community Hospital; Suspended

Bakersfield, California, United States, 93301

Alta Bates Summit Medical Center-Herrick Campus; Suspended

Berkeley, California, United States, 94704

Sutter Cancer Centers Radiation Oncology Services-Cameron Park; Suspended

Cameron Park, California, United States, 95682

Eden Hospital Medical Center; Suspended

Castro Valley, California, United States, 94546

Marin General Hospital; Active, not recruiting

Greenbrae, California, United States, 94904

Loma Linda University Medical Center; Recruiting

Loma Linda, California, United States, 92354

Contact: Site Public Contact 909-558-3375

Principal Investigator: Joseph I. Kang

Los Angeles County-USC Medical Center; Suspended

Los Angeles, California, United States, 90033

USC / Norris Comprehensive Cancer Center; Suspended

Los Angeles, California, United States, 90033

Cedars Sinai Medical Center; Suspended

Los Angeles, California, United States, 90048

Fremont - Rideout Cancer Center; Suspended

Marysville, California, United States, 95901

Memorial Medical Center; Suspended

Modesto, California, United States, 95355

Kaiser Permanente Oakland-Broadway; Suspended

Oakland, California, United States, 94611

Saint Joseph Hospital - Orange; Active, not recruiting

Orange, California, United States, 92868

UC Irvine Health/Chao Family Comprehensive Cancer Center; Suspended

Orange, California, United States, 92868

Palo Alto Medical Foundation Health Care; Suspended

Palo Alto, California, United States, 94301

Pomona Valley Hospital Medical Center; Active, not recruiting

Pomona, California, United States, 91767

Kaiser Permanente-Rancho Cordova Cancer Center; Suspended

Rancho Cordova, California, United States, 95670

Rohnert Park Cancer Center; Suspended

Rohnert Park, California, United States, 94928

Sutter Cancer Centers Radiation Oncology Services-Roseville; Suspended

Roseville, California, United States, 95661

The Permanente Medical Group-Roseville Radiation Oncology; Suspended

Roseville, California, United States, 95678

Sutter Medical Center Sacramento; Suspended

Sacramento, California, United States, 95816

University of California Davis Comprehensive Cancer Center; Suspended

Sacramento, California, United States, 95817

South Sacramento Cancer Center; Suspended

Sacramento, California, United States, 95823

California Pacific Medical Center-Pacific Campus; Suspended

San Francisco, California, United States, 94115

Palo Alto Medical Foundation-Santa Cruz; Suspended

Santa Cruz, California, United States, 95065

Kaiser Permanente Cancer Treatment Center; Suspended

South San Francisco, California, United States, 94080

Palo Alto Medical Foundation-Sunnyvale; Suspended

Sunnyvale, California, United States, 94086

Sutter Cancer Centers Radiation Oncology Services-Vacaville; Suspended

Vacaville, California, United States, 95687

John Muir Medical Center-Walnut Creek; Active, not recruiting

Walnut Creek, California, United States, 94598

United States, Colorado

UCHealth Memorial Hospital Central; Suspended

Colorado Springs, Colorado, United States, 80909

Poudre Valley Hospital; Suspended

Fort Collins, Colorado, United States, 80524

United States, Connecticut

Hartford Hospital; Suspended

Hartford, Connecticut, United States, 06102

United States, Florida

Boca Raton Regional Hospital; Active, not recruiting

Boca Raton, Florida, United States, 33486

University of Florida Health Science Center - Gainesville; Suspended

Gainesville, Florida, United States, 32610

Baptist MD Anderson Cancer Center; Active, not recruiting

Jacksonville, Florida, United States, 32207

University of Florida Health Science Center - Jacksonville; Suspended

Jacksonville, Florida, United States, 32209

Baptist Medical Center South; Active, not recruiting

Jacksonville, Florida, United States, 32258

Miami Cancer Institute; Recruiting

Miami, Florida, United States, 33176

Contact: Site Public Contact 786-596-2000

Principal Investigator: Minesh P. Mehta

Moffitt Cancer Center; Suspended

Tampa, Florida, United States, 33612

United States, Georgia

Emory Proton Therapy Center; Recruiting

Atlanta, Georgia, United States, 30308

Contact: Site Public Contact 404-251-2854 allyson.anderson@emory.edu

Principal Investigator: Hui-Kuo G. Shu

Emory University Hospital Midtown; Recruiting

Atlanta, Georgia, United States, 30308

Contact: Site Public Contact 888-946-7447

Principal Investigator: Hui-Kuo G. Shu

Emory University Hospital/Winship Cancer Institute; Recruiting

Atlanta, Georgia, United States, 30322

Contact: Site Public Contact 404-778-1868

Principal Investigator: Hui-Kuo G. Shu

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler; Suspended

Savannah, Georgia, United States, 31405

United States, Idaho

Saint Alphonsus Cancer Care Center-Boise; Active, not recruiting

Boise, Idaho, United States, 83706

United States, Illinois

Northwestern University; Suspended

Chicago, Illinois, United States, 60611

John H Stroger Jr Hospital of Cook County; Suspended

Chicago, Illinois, United States, 60612

Rush University Medical Center; Suspended

Chicago, Illinois, United States, 60612

University of Chicago Comprehensive Cancer Center; Active, not recruiting

Chicago, Illinois, United States, 60637

Decatur Memorial Hospital; Suspended

Decatur, Illinois, United States, 62526

Northwestern Medicine Cancer Center Kishwaukee; Recruiting

DeKalb, Illinois, United States, 60115

Contact: Site Public Contact 630-315-1918 claudine.gamster@nm.org

Principal Investigator: Vinai Gondi

Northwestern Medicine Cancer Center Delnor; Recruiting

Geneva, Illinois, United States, 60134

Contact: Site Public Contact 630-315-1918 Claudine.Gamster@CadenceHealth.org

Principal Investigator: Vinai Gondi

UC Comprehensive Cancer Center at Silver Cross; Suspended

New Lenox, Illinois, United States, 60451

Advocate Lutheran General Hospital; Active, not recruiting

Park Ridge, Illinois, United States, 60068

OSF Saint Francis Medical Center; Suspended

Peoria, Illinois, United States, 61637

Memorial Medical Center; Recruiting

Springfield, Illinois, United States, 62781

Contact: Site Public Contact 217-788-3528

Principal Investigator: Bryan A. Faller

Northwestern Medicine Cancer Center Warrenville; Recruiting

Warrenville, Illinois, United States, 60555

Contact: Site Public Contact 630-315-1918 Claudine.Gamster@CadenceHealth.org

Principal Investigator: Vinai Gondi

United States, Indiana

Radiation Oncology Associates PC; Suspended

Fort Wayne, Indiana, United States, 46804

Parkview Hospital Randallia; Active, not recruiting

Fort Wayne, Indiana, United States, 46805

Parkview Regional Medical Center; Active, not recruiting

Fort Wayne, Indiana, United States, 46845

IU Health Methodist Hospital; Active, not recruiting

Indianapolis, Indiana, United States, 46202

Community Cancer Center East; Active, not recruiting

Indianapolis, Indiana, United States, 46219

Community Cancer Center South; Active, not recruiting

Indianapolis, Indiana, United States, 46227

Community Cancer Center North; Active, not recruiting

Indianapolis, Indiana, United States, 46256

IU Health Ball Memorial Hospital; Active, not recruiting

Muncie, Indiana, United States, 47303

United States, Iowa

Mercy Hospital; Active, not recruiting

Cedar Rapids, Iowa, United States, 52403

Iowa Methodist Medical Center; Active, not recruiting

Des Moines, Iowa, United States, 50309

United States, Kansas

University of Kansas Cancer Center; Suspended

Kansas City, Kansas, United States, 66160

University of Kansas Cancer Center-Overland Park; Suspended

Overland Park, Kansas, United States, 66210

United States, Kentucky

Norton Hospital Pavilion and Medical Campus; Active, not recruiting

Louisville, Kentucky, United States, 40202

United States, Louisiana

Ochsner Medical Center Jefferson; Active, not recruiting

New Orleans, Louisiana, United States, 70121

Willis-Knighton Medical and Cancer Center; Active, not recruiting

Shreveport, Louisiana, United States, 71103

United States, Maryland

Maryland Proton Treatment Center; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Site Public Contact 410-369-5226 info@mdproton.com

Principal Investigator: Mark V. Mishra

University of Maryland/Greenebaum Cancer Center; Suspended

Baltimore, Maryland, United States, 21201

UM Upper Chesapeake Medical Center; Recruiting

Bel Air, Maryland, United States, 21014

Contact: Site Public Contact 443-643-3010

Principal Investigator: Jack J. Hong

Central Maryland Radiation Oncology in Howard County; Suspended

Columbia, Maryland, United States, 21044

UM Baltimore Washington Medical Center/Tate Cancer Center; Suspended

Glen Burnie, Maryland, United States, 21061

United States, Massachusetts

Tufts Medical Center; Active, not recruiting

Boston, Massachusetts, United States, 02111

Massachusetts General Hospital Cancer Center; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Site Public Contact 877-726-5130

Principal Investigator: Helen A. Shih

Boston Medical Center; Active, not recruiting

Boston, Massachusetts, United States, 02118

Mass General/North Shore Cancer Center; Suspended

Danvers, Massachusetts, United States, 01923

Lowell General Hospital; Active, not recruiting

Lowell, Massachusetts, United States, 01854

United States, Michigan

Saint Joseph Mercy Hospital; Suspended

Ann Arbor, Michigan, United States, 48106

University of Michigan Comprehensive Cancer Center; Active, not recruiting

Ann Arbor, Michigan, United States, 48109

Beaumont Hospital - Dearborn; Recruiting

Dearborn, Michigan, United States, 48124

Contact: Site Public Contact 248-551-7695

Principal Investigator: Prakash Chinnaiyan

Henry Ford Hospital; Active, not recruiting

Detroit, Michigan, United States, 48202

McLaren Cancer Institute-Flint; Active, not recruiting

Flint, Michigan, United States, 48532

Mercy Health Saint Mary's; Active, not recruiting

Grand Rapids, Michigan, United States, 49503

Spectrum Health at Butterworth Campus; Active, not recruiting

Grand Rapids, Michigan, United States, 49503

West Michigan Cancer Center; Recruiting

Kalamazoo, Michigan, United States, 49007

Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org

Principal Investigator: Kathleen J. Yost

McLaren Cancer Institute-Lapeer Region; Active, not recruiting

Lapeer, Michigan, United States, 48446

Saint Mary Mercy Hospital; Suspended

Livonia, Michigan, United States, 48154

McLaren Cancer Institute-Macomb; Active, not recruiting

Mount Clemens, Michigan, United States, 48043

McLaren Cancer Institute-Central Michigan; Active, not recruiting

Mount Pleasant, Michigan, United States, 48858

McLaren Cancer Institute-Owosso; Active, not recruiting

Owosso, Michigan, United States, 48867

McLaren Cancer Institute-Northern Michigan; Active, not recruiting

Petoskey, Michigan, United States, 49770

Saint Joseph Mercy Oakland; Suspended

Pontiac, Michigan, United States, 48341

William Beaumont Hospital-Royal Oak; Recruiting

Royal Oak, Michigan, United States, 48073

Contact: Site Public Contact 248-551-7695

Principal Investigator: Prakash Chinnaiyan

Lakeland Medical Center Saint Joseph; Active, not recruiting

Saint Joseph, Michigan, United States, 49085

William Beaumont Hospital - Troy; Recruiting

Troy, Michigan, United States, 48085

Contact: Site Public Contact 248-551-7695

Principal Investigator: Prakash Chinnaiyan

United States, Minnesota

Sanford Joe Lueken Cancer Center; Suspended

Bemidji, Minnesota, United States, 56601

Saint Luke's Hospital of Duluth; Active, not recruiting

Duluth, Minnesota, United States, 55805

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Site Public Contact 855-776-0015

Principal Investigator: Sujay A. Vora

Coborn Cancer Center at Saint Cloud Hospital; Active, not recruiting

Saint Cloud, Minnesota, United States, 56303

Regions Hospital; Active, not recruiting

Saint Paul, Minnesota, United States, 55101

United States, Mississippi

University of Mississippi Medical Center; Active, not recruiting

Jackson, Mississippi, United States, 39216

United States, Missouri

North Kansas City Hospital; Suspended

Kansas City, Missouri, United States, 64116

The University of Kansas Cancer Center-North; Suspended

Kansas City, Missouri, United States, 64154

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu

Principal Investigator: Jiayi Huang

United States, Montana

Billings Clinic Cancer Center; Suspended

Billings, Montana, United States, 59101

United States, Nevada

Comprehensive Cancer Centers of Nevada; Active, not recruiting

Las Vegas, Nevada, United States, 89148

Renown Regional Medical Center; Active, not recruiting

Reno, Nevada, United States, 89502

Saint Mary's Regional Medical Center; Active, not recruiting

Reno, Nevada, United States, 89503

United States, New Hampshire

Dartmouth Hitchcock Medical Center; Active, not recruiting

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

Memorial Sloan Kettering Basking Ridge; Suspended

Basking Ridge, New Jersey, United States, 07920

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital; Suspended

New Brunswick, New Jersey, United States, 08903

Rutgers Cancer Institute of New Jersey; Suspended

New Brunswick, New Jersey, United States, 08903

Capital Health Medical Center-Hopewell; Active, not recruiting

Pennington, New Jersey, United States, 08534

ProCure Proton Therapy Center-Somerset; Suspended

Somerset, New Jersey, United States, 08873

Virtua Voorhees; Active, not recruiting

Voorhees, New Jersey, United States, 08043

United States, New York

Montefiore Medical Center - Moses Campus; Active, not recruiting

Bronx, New York, United States, 10467

New York-Presbyterian/Brooklyn Methodist Hospital; Suspended

Brooklyn, New York, United States, 11215

Memorial Sloan Kettering Commack; Suspended

Commack, New York, United States, 11725

Memorial Sloan Kettering Westchester; Suspended

Harrison, New York, United States, 10604

Northwell Health/Center for Advanced Medicine; Active, not recruiting

Lake Success, New York, United States, 11042

Laura and Isaac Perlmutter Cancer Center at NYU Langone; Recruiting

New York, New York, United States, 10016

Contact: Site Public Contact 212-263-4434 prmc.coordinator@nyumc.org

Principal Investigator: Joshua S. Silverman

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center; Active, not recruiting

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center; Recruiting

New York, New York, United States, 10065

Contact: Site Public Contact 212-639-7592

Principal Investigator: Thomas J. Kaley

United States, North Carolina

Mission Hospital; Active, not recruiting

Asheville, North Carolina, United States, 28801

Novant Health Forsyth Medical Center; Active, not recruiting

Winston-Salem, North Carolina, United States, 27103

Wake Forest University Health Sciences; Active, not recruiting

Winston-Salem, North Carolina, United States, 27157

United States, North Dakota

Sanford Bismarck Medical Center; Suspended

Bismarck, North Dakota, United States, 58501

Sanford Roger Maris Cancer Center; Suspended

Fargo, North Dakota, United States, 58122

United States, Ohio

Cleveland Clinic Akron General; Suspended

Akron, Ohio, United States, 44307

UHHS-Chagrin Highlands Medical Center; Suspended

Beachwood, Ohio, United States, 44122

Geauga Hospital; Recruiting

Chardon, Ohio, United States, 44024

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

University of Cincinnati/Barrett Cancer Center; Recruiting

Cincinnati, Ohio, United States, 45219

Contact: Site Public Contact 513-558-4553 uchealthnews@uc.edu

Principal Investigator: Jordan Kharofa

Case Western Reserve University; Recruiting

Cleveland, Ohio, United States, 44106

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

Cleveland Clinic Cancer Center/Fairview Hospital; Suspended

Cleveland, Ohio, United States, 44111

Cleveland Clinic Foundation; Suspended

Cleveland, Ohio, United States, 44195

Ohio State University Comprehensive Cancer Center; Active, not recruiting

Columbus, Ohio, United States, 43210

Riverside Methodist Hospital; Active, not recruiting

Columbus, Ohio, United States, 43214

Mercy Cancer Center-Elyria; Recruiting

Elyria, Ohio, United States, 44035

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

Cleveland Clinic Cancer Center Independence; Suspended

Independence, Ohio, United States, 44131

Hillcrest Hospital Cancer Center; Suspended

Mayfield Heights, Ohio, United States, 44124

UH Seidman Cancer Center at Lake Health Mentor Campus; Recruiting

Mentor, Ohio, United States, 44060

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

UH Seidman Cancer Center at Southwest General Hospital; Recruiting

Middleburg Heights, Ohio, United States, 44130

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

University Hospitals Parma Medical Center; Recruiting

Parma, Ohio, United States, 44129

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

North Coast Cancer Care; Suspended

Sandusky, Ohio, United States, 44870

UH Seidman Cancer Center at Firelands Regional Medical Center; Recruiting

Sandusky, Ohio, United States, 44870

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

Cleveland Clinic Cancer Center Strongsville; Suspended

Strongsville, Ohio, United States, 44136

University of Toledo; Active, not recruiting

Toledo, Ohio, United States, 43614

University Pointe; Recruiting

West Chester, Ohio, United States, 45069

Contact: Site Public Contact clinicaltrials@ucphysicians.com

Principal Investigator: Jordan Kharofa

UHHS-Westlake Medical Center; Recruiting

Westlake, Ohio, United States, 44145

Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org

Principal Investigator: Mitchell Machtay

Cleveland Clinic Wooster Family Health and Surgery Center; Suspended

Wooster, Ohio, United States, 44691

United States, Oklahoma

University of Oklahoma Health Sciences Center; Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contact: Site Public Contact 405-271-8777 ou-clinical-trials@ouhsc.edu

Principal Investigator: J. S. Thompson

United States, Oregon

Willamette Valley Cancer Center; Suspended

Eugene, Oregon, United States, 97401

Legacy Mount Hood Medical Center; Active, not recruiting

Gresham, Oregon, United States, 97030

Legacy Good Samaritan Hospital and Medical Center; Active, not recruiting

Portland, Oregon, United States, 97210

United States, Pennsylvania

Saint Luke's University Hospital-Bethlehem Campus; Active, not recruiting

Bethlehem, Pennsylvania, United States, 18015

Northeast Radiation Oncology Center; Active, not recruiting

Dunmore, Pennsylvania, United States, 18512

Ephrata Cancer Center; Recruiting

Ephrata, Pennsylvania, United States, 17522

Contact: Site Public Contact 717-721-4840

Principal Investigator: Amit B. Shah

Adams Cancer Center; Suspended

Gettysburg, Pennsylvania, United States, 17325

UPMC Pinnacle Cancer Center/Community Osteopathic Campus; Suspended

Harrisburg, Pennsylvania, United States, 17109

Sechler Family Cancer Center; Recruiting

Lebanon, Pennsylvania, United States, 17042

Contact: Site Public Contact 717-741-8303 doxenberg@wellspan.org

Principal Investigator: Amit B. Shah

University of Pennsylvania/Abramson Cancer Center; Suspended

Philadelphia, Pennsylvania, United States, 19104

Thomas Jefferson University Hospital; Suspended

Philadelphia, Pennsylvania, United States, 19107

Aria Health-Torresdale Campus; Suspended

Philadelphia, Pennsylvania, United States, 19114

Reading Hospital; Suspended

West Reading, Pennsylvania, United States, 19611

WellSpan Health-York Cancer Center; Recruiting

York, Pennsylvania, United States, 17403

Contact: Site Public Contact 877-441-7957

Principal Investigator: Amit B. Shah

United States, South Carolina

Medical University of South Carolina; Active, not recruiting

Charleston, South Carolina, United States, 29425

Prisma Health Cancer Institute - Faris; Suspended

Greenville, South Carolina, United States, 29605

Prisma Health Cancer Institute - Eastside; Suspended

Greenville, South Carolina, United States, 29615

Self Regional Healthcare; Active, not recruiting

Greenwood, South Carolina, United States, 29646

Prisma Health Cancer Institute - Greer; Suspended

Greer, South Carolina, United States, 29650

Prisma Health Cancer Institute - Seneca; Suspended

Seneca, South Carolina, United States, 29672

Prisma Health Cancer Institute - Spartanburg; Suspended

Spartanburg, South Carolina, United States, 29307

United States, South Dakota

Sanford USD Medical Center - Sioux Falls; Suspended

Sioux Falls, South Dakota, United States, 57117-5134

United States, Tennessee

Tennessee Cancer Specialists-Dowell Springs; Suspended

Knoxville, Tennessee, United States, 37909

United States, Texas

Dell Seton Medical Center at The University of Texas; Active, not recruiting

Austin, Texas, United States, 78701

Austin Cancer Centers-Central Austin; Active, not recruiting

Austin, Texas, United States, 78702

Texas Oncology-Austin Midtown; Suspended

Austin, Texas, United States, 78705

Texas Oncology - Central Austin Cancer Center; Suspended

Austin, Texas, United States, 78731

Texas Oncology - South Austin Cancer Center; Suspended

Austin, Texas, United States, 78745

Austin Cancer Centers-North; Suspended

Austin, Texas, United States, 78758

UT Southwestern/Simmons Cancer Center-Dallas; Active, not recruiting

Dallas, Texas, United States, 75390

Texas Oncology-Flower Mound; Suspended

Flower Mound, Texas, United States, 75028

Texas Oncology - Fort Worth Cancer Center; Suspended

Fort Worth, Texas, United States, 76104

University of Texas Medical Branch; Active, not recruiting

Galveston, Texas, United States, 77555-0565

Memorial Hermann Memorial City Medical Center; Active, not recruiting

Houston, Texas, United States, 77024

M D Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org

Principal Investigator: Andrew J. Bishop

UTMB Cancer Center at Victory Lakes; Active, not recruiting

League City, Texas, United States, 77573

Covenant Medical Center-Lakeside; Active, not recruiting

Lubbock, Texas, United States, 79410

Texas Oncology-Seton Williamson; Suspended

Round Rock, Texas, United States, 78665

Texas Oncology - Round Rock Cancer Center; Suspended

Round Rock, Texas, United States, 78681

University of Texas Health Science Center at San Antonio; Suspended

San Antonio, Texas, United States, 78229

Texas Cancer Center-Sherman; Suspended

Sherman, Texas, United States, 75090

Texas Oncology Cancer Center Sugar Land; Suspended

Sugar Land, Texas, United States, 77479

Tyler Cancer Center; Suspended

Tyler, Texas, United States, 75702

United States, Utah

Logan Regional Hospital; Suspended

Logan, Utah, United States, 84321

Intermountain Medical Center; Suspended

Murray, Utah, United States, 84107

McKay-Dee Hospital Center; Suspended

Ogden, Utah, United States, 84403

Utah Valley Regional Medical Center; Suspended

Provo, Utah, United States, 84604

Dixie Medical Center Regional Cancer Center; Suspended

Saint George, Utah, United States, 84770

Huntsman Cancer Institute/University of Utah; Suspended

Salt Lake City, Utah, United States, 84112

United States, Vermont

Central Vermont Medical Center/National Life Cancer Treatment; Suspended

Berlin, Vermont, United States, 05602

University of Vermont Medical Center; Suspended

Burlington, Vermont, United States, 05401

Norris Cotton Cancer Center-North; Active, not recruiting

Saint Johnsbury, Vermont, United States, 05819

United States, Virginia

Virginia Commonwealth University/Massey Cancer Center; Suspended

Richmond, Virginia, United States, 23298

United States, Washington

SCCA Proton Therapy Center; Recruiting

Seattle, Washington, United States, 98133

Contact: Site Public Contact 206-306-2800

Principal Investigator: Lia M. Halasz

Seattle Cancer Care Alliance at Northwest Hospital; Recruiting

Seattle, Washington, United States, 98133

Contact: Site Public Contact 206-606-5800

Principal Investigator: Lia M. Halasz

University of Washington Medical Center; Recruiting

Seattle, Washington, United States, 98195

Contact: Site Public Contact 800-804-8824

Principal Investigator: Lia M. Halasz

Compass Oncology Vancouver; Suspended

Vancouver, Washington, United States, 98684

Legacy Salmon Creek Hospital; Active, not recruiting

Vancouver, Washington, United States, 98686

United States, West Virginia

Wheeling Hospital/Schiffler Cancer Center; Suspended

Wheeling, West Virginia, United States, 26003

United States, Wisconsin

Langlade Hospital and Cancer Center; Active, not recruiting

Antigo, Wisconsin, United States, 54409

Gundersen Lutheran Medical Center; Active, not recruiting

La Crosse, Wisconsin, United States, 54601

University of Wisconsin Hospital and Clinics; Active, not recruiting

Madison, Wisconsin, United States, 53792

Froedtert Menomonee Falls Hospital; Suspended

Menomonee Falls, Wisconsin, United States, 53051

Medical College of Wisconsin; Suspended

Milwaukee, Wisconsin, United States, 53226

UW Cancer Center at ProHealth Care; Active, not recruiting

Waukesha, Wisconsin, United States, 53188

Aspirus Regional Cancer Center; Active, not recruiting

Wausau, Wisconsin, United States, 54401

Canada, British Columbia

BCCA-Vancouver Island Cancer Centre; Suspended

Victoria, British Columbia, Canada, V8R 6V5

Canada, Ontario

Ottawa Hospital and Cancer Center-General Campus; Active, not recruiting

Ottawa, Ontario, Canada, K1H 8L6

Windsor Regional Cancer Centre; Suspended

Windsor, Ontario, Canada, N8W 2X3

Canada, Quebec

CHUM - Hopital Notre-Dame; Recruiting

Montreal, Quebec, Canada, H2L 4M1

Contact: Jean-Paul Bahary 514-890-8000 ext 14788 marie-josee.samson.chum@ssss.gouv.qc.ca

Principal Investigator: Jean-Paul Bahary

McGill University Department of Oncology; Suspended

Montreal, Quebec, Canada, H2W 1S6

CHUM - Centre Hospitalier de l'Universite de Montreal; Suspended

Montreal, Quebec, Canada, H2X 3E4

The Research Institute of the McGill University Health Centre (MUHC); Suspended

Montreal, Quebec, Canada, H3H 2R9

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ); Suspended

Quebec City, Quebec, Canada, G1R 2J6

Canada, Saskatchewan

Saskatoon Cancer Centre; Active, not recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Sponsors and Collaborators

NRG Oncology

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Investigators

• Principal Investigator: Minesh Mehta; NRG Oncology

More Information

• Responsible Party: NRG Oncology
• ClinicalTrials.gov Identifier: NCT02179086
• Obsolete Identifiers: NCT02163135
• Other Study ID Numbers: NRG-BN001; NCI-2014-01072 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); NRG-BN001 ( Other Identifier: NRG Oncology ); NRG-BN001 ( Other Identifier: CTEP ); U10CA180868 ( U.S. NIH Grant/Contract )
• First Posted: July 1, 2014
• Last Update Posted: April 21, 2020
• Last Verified: April 2020

Additional relevant MeSH terms:

Glioblastoma; Gliosarcoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Temozolomide; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents