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

Study Description

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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

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Study Design

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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 2019
Estimated Study Completion Date :	May 2024

Arms and Interventions

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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

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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

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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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	Recruiting
Phoenix, Arizona, United States, 85013
Contact: David G. Brachman 800-360-6371
Principal Investigator: David G. Brachman
Arizona Oncology Associates-West Orange Grove	Active, not recruiting
Tucson, Arizona, United States, 85704
The University of Arizona Medical Center-University Campus	Recruiting
Tucson, Arizona, United States, 85724
Contact: Baldassarre Stea 520-626-9008
Principal Investigator: Baldassarre Stea
United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Sanjay Maraboyina 501-686-8274
Principal Investigator: Sanjay Maraboyina
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn	Recruiting
Auburn, California, United States, 95603
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
AIS Cancer Center at San Joaquin Community Hospital	Recruiting
Bakersfield, California, United States, 93301
Contact: Ruben C. Fragoso 661-323-4673
Principal Investigator: Ruben C. Fragoso
Alta Bates Summit Medical Center-Herrick Campus	Recruiting
Berkeley, California, United States, 94704
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
Sutter Cancer Centers Radiation Oncology Services-Cameron Park	Recruiting
Cameron Park, California, United States, 95682
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
Eden Hospital Medical Center	Recruiting
Castro Valley, California, United States, 94546
Contact: Christopher U. Jones 510-537-1234
Principal Investigator: Christopher U. Jones
Loma Linda University Medical Center	Recruiting
Loma Linda, California, United States, 92354
Contact: Joseph I. Kang 909-558-3375
Principal Investigator: Joseph I. Kang
Los Angeles County-USC Medical Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Richard L. Jennelle 323-865-0451
Principal Investigator: Richard L. Jennelle
USC / Norris Comprehensive Cancer Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Richard L. Jennelle 323-865-0451
Principal Investigator: Richard L. Jennelle
Cedars Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Stephen L. Shiao 310-423-8965
Principal Investigator: Stephen L. Shiao
Fremont - Rideout Cancer Center	Recruiting
Marysville, California, United States, 95901
Contact: Ruben C. Fragoso 530-749-4400
Principal Investigator: Ruben C. Fragoso
Memorial Medical Center	Recruiting
Modesto, California, United States, 95355
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
Kaiser Permanente Oakland-Broadway	Recruiting
Oakland, California, United States, 94611
Contact: Samantha A. Seaward 510-891-3400
Principal Investigator: Samantha A. Seaward
Saint Joseph Hospital - Orange	Active, not recruiting
Orange, California, United States, 92868
UC Irvine Health/Chao Family Comprehensive Cancer Center	Recruiting
Orange, California, United States, 92868
Contact: Xiao-Tang Kong 877-827-8839 ucstudy@uci.edu
Principal Investigator: Xiao-Tang Kong
Palo Alto Medical Foundation Health Care	Recruiting
Palo Alto, California, United States, 94301
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
Pomona Valley Hospital Medical Center	Suspended
Pomona, California, United States, 91767
Kaiser Permanente-Rancho Cordova Cancer Center	Recruiting
Rancho Cordova, California, United States, 95670
Contact: Samantha A. Seaward 510-891-3400
Principal Investigator: Samantha A. Seaward
Rohnert Park Cancer Center	Recruiting
Rohnert Park, California, United States, 94928
Contact: Samantha A. Seaward 707-584-2200
Principal Investigator: Samantha A. Seaward
Sutter Cancer Centers Radiation Oncology Services-Roseville	Recruiting
Roseville, California, United States, 95661
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
The Permanente Medical Group-Roseville Radiation Oncology	Recruiting
Roseville, California, United States, 95678
Contact: Samantha A. Seaward 510-891-3400
Principal Investigator: Samantha A. Seaward
Sutter Medical Center Sacramento	Recruiting
Sacramento, California, United States, 95816
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
University of California Davis Comprehensive Cancer Center	Recruiting
Sacramento, California, United States, 95817
Contact: Ruben C. Fragoso 916-734-3089
Principal Investigator: Ruben C. Fragoso
South Sacramento Cancer Center	Recruiting
Sacramento, California, United States, 95823
Contact: Samantha A. Seaward 916-683-9616
Principal Investigator: Samantha A. Seaward
California Pacific Medical Center-Pacific Campus	Recruiting
San Francisco, California, United States, 94115
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
Palo Alto Medical Foundation-Santa Cruz	Recruiting
Santa Cruz, California, United States, 95065
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
Kaiser Permanente Cancer Treatment Center	Recruiting
South San Francisco, California, United States, 94080
Contact: Samantha A. Seaward 510-891-3400
Principal Investigator: Samantha A. Seaward
Palo Alto Medical Foundation-Sunnyvale	Recruiting
Sunnyvale, California, United States, 94086
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
Sutter Cancer Centers Radiation Oncology Services-Vacaville	Recruiting
Vacaville, California, United States, 95687
Contact: Christopher U. Jones 415-209-2686 bernicl@sutterhealth.org
Principal Investigator: Christopher U. Jones
John Muir Medical Center-Walnut Creek	Active, not recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
UCHealth Memorial Hospital Central	Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Anthony D. Elias 719-365-2406
Principal Investigator: Anthony D. Elias
Poudre Valley Hospital	Suspended
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Hartford Hospital	Recruiting
Hartford, Connecticut, United States, 06102
Contact: Susan Y. Kim 860-545-5363
Principal Investigator: Susan Y. Kim
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	Recruiting
Jacksonville, Florida, United States, 32209
Contact: Ronny L. Rotondo 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Ronny L. Rotondo
Baptist Medical Center South	Active, not recruiting
Jacksonville, Florida, United States, 32258
Moffitt Cancer Center	Suspended
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital/Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Hui-Kuo G. Shu 404-778-1868
Principal Investigator: Hui-Kuo G. Shu
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Recruiting
Savannah, Georgia, United States, 31405
Contact: Howard A. Zaren 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Howard A. Zaren
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise	Recruiting
Boise, Idaho, United States, 83706
Contact: Samir Narayan 734-712-3671
Principal Investigator: Samir Narayan
United States, Illinois
Northwestern University	Suspended
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County	Recruiting
Chicago, Illinois, United States, 60612
Contact: Thomas E. Lad 312-864-5204
Principal Investigator: Thomas E. Lad
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Aidnag Z. Diaz 312-942-5498 clinical_trials@rush.edu
Principal Investigator: Aidnag Z. Diaz
University of Chicago Comprehensive Cancer Center	Suspended
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital	Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade 217-876-6601
Principal Investigator: James L. Wade
Northwestern Medicine Cancer Center Delnor	Recruiting
Geneva, Illinois, United States, 60134
Contact: Vinai Gondi 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	Recruiting
Peoria, Illinois, United States, 61637
Contact: James L. Wade 309-243-3605 andersonj@illinoiscancercare.com
Principal Investigator: James L. Wade
Memorial Medical Center	Suspended
Springfield, Illinois, United States, 62781
Northwestern Medicine Cancer Center Warrenville	Recruiting
Warrenville, Illinois, United States, 60555
Contact: Vinai Gondi 630-315-1918 Claudine.Gamster@CadenceHealth.org
Principal Investigator: Vinai Gondi
United States, Indiana
Radiation Oncology Associates PC	Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang 877-437-2408
Principal Investigator: Brian K. Chang
Parkview Hospital Randallia	Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang 260-373-8888 parkviewresearch@parkview.com
Principal Investigator: Brian K. Chang
IU Health Methodist Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Gordon A. Watson 317-962-5731
Principal Investigator: Gordon A. Watson
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	Suspended
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	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Joshua M. Mammen 913-945-7552 ctnursenav@kumc.edu
Principal Investigator: Joshua M. Mammen
University of Kansas Cancer Center-Overland Park	Recruiting
Overland Park, Kansas, United States, 66210
Contact: Joshua M. Mammen 913-945-7552 ctnursenav@kumc.edu
Principal Investigator: Joshua M. Mammen
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	Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Augusto C. Ochoa 318-212-8671 bbarrow@wkhs.com
Principal Investigator: Augusto C. Ochoa
United States, Maryland
Maryland Proton Treatment Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark V. Mishra 410-369-5226 info@mdproton.com
Principal Investigator: Mark V. Mishra
University of Maryland/Greenebaum Cancer Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark V. Mishra 800-888-8823
Principal Investigator: Mark V. Mishra
Upper Chesapeake Medical Center	Recruiting
Bel Air, Maryland, United States, 21014
Contact: Mark V. Mishra 443-643-3010
Principal Investigator: Mark V. Mishra
Central Maryland Radiation Oncology in Howard County	Recruiting
Columbia, Maryland, United States, 21044
Contact: Mark V. Mishra 443-546-1300
Principal Investigator: Mark V. Mishra
Tate Cancer Center	Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Mark V. Mishra 410-553-8100
Principal Investigator: Mark V. Mishra
United States, Massachusetts
Tufts Medical Center	Suspended
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Helen A. Shih 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	Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Helen A. Shih 978-882-6032 lfabry@partners.org
Principal Investigator: Helen A. Shih
Lowell General Hospital	Active, not recruiting
Lowell, Massachusetts, United States, 01854
United States, Michigan
Saint Joseph Mercy Hospital	Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Samir Narayan 734-712-3671
Principal Investigator: Samir Narayan
University of Michigan Comprehensive Cancer Center	Active, not recruiting
Ann Arbor, Michigan, United States, 48109
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	Active, not recruiting
Kalamazoo, Michigan, United States, 49007
McLaren Cancer Institute-Lapeer Region	Active, not recruiting
Lapeer, Michigan, United States, 48446
Saint Mary Mercy Hospital	Recruiting
Livonia, Michigan, United States, 48154
Contact: Samir Narayan 734-712-3671
Principal Investigator: Samir Narayan
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	Recruiting
Pontiac, Michigan, United States, 48341
Contact: Samir Narayan 734-712-3671
Principal Investigator: Samir Narayan
Lakeland Medical Center Saint Joseph	Active, not recruiting
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
Sanford Clinic North-Bemidgi	Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston D. Steen 218-333-5000
Principal Investigator: Preston D. Steen
Saint Luke's Hospital of Duluth	Recruiting
Duluth, Minnesota, United States, 55805
Contact: Steven R. Bonin 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Steven R. Bonin
Coborn Cancer Center at Saint Cloud Hospital	Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens 877-229-4907 coborncancercenter@centracare.com
Principal Investigator: Donald J. Jurgens
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	Recruiting
Kansas City, Missouri, United States, 64116
Contact: Joshua M. Mammen 816-691-1599
Principal Investigator: Joshua M. Mammen
The University of Kansas Cancer Center-North	Recruiting
Kansas City, Missouri, United States, 64154
Contact: Joshua M. Mammen 913-945-7552 ctnursenav@kumc.edu
Principal Investigator: Joshua M. Mammen
Washington University School of Medicine	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jiayi Huang 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
Renown Regional Medical Center	Recruiting
Reno, Nevada, United States, 89502
Contact: John A. Ellerton 702-384-0013 research@sncrf.org
Principal Investigator: John A. Ellerton
Saint Mary's Regional Medical Center	Recruiting
Reno, Nevada, United States, 89503
Contact: John A. Ellerton 412-339-5294 Roster@nrgoncology.org
Principal Investigator: John A. Ellerton
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	Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Mariza Daras 212-639-7202
Principal Investigator: Mariza Daras
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital	Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Atif J. Khan 732-235-8675
Principal Investigator: Atif J. Khan
Rutgers Cancer Institute of New Jersey	Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Atif J. Khan 732-235-8675
Principal Investigator: Atif J. Khan
Capital Health Medical Center-Hopewell	Recruiting
Pennington, New Jersey, United States, 08534
Contact: Shirnett K. Williamson 800-255-3440
Principal Investigator: Shirnett K. Williamson
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	Recruiting
Brooklyn, New York, United States, 11215
Contact: Hani L. Ashamalla 718-780-3677 Adg9003@nyp.org
Principal Investigator: Hani L. Ashamalla
Memorial Sloan Kettering Commack	Recruiting
Commack, New York, United States, 11725
Contact: Mariza Daras 212-639-7202
Principal Investigator: Mariza Daras
Memorial Sloan Kettering Westchester	Recruiting
Harrison, New York, United States, 10604
Contact: Mariza Daras 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Mariza Daras
Northwell Health/Center for Advanced Medicine	Active, not recruiting
New Hyde Park, New York, United States, 11042
Columbia University/Herbert Irving 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: Mariza Daras 212-639-7202
Principal Investigator: Mariza Daras
United States, North Carolina
Mission Hospital-Memorial Campus	Recruiting
Asheville, North Carolina, United States, 28801
Contact: Christopher H. Chay 828-213-4150
Principal Investigator: Christopher H. Chay
Novant Health Forsyth Medical Center	Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Michael D. Chan 336-713-6771
Principal Investigator: Michael D. Chan
United States, North Dakota
Sanford Bismarck Medical Center	Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Preston D. Steen 701-323-5760 tamara.fischer@sanfordhealth.org
Principal Investigator: Preston D. Steen
Roger Maris Cancer Center	Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen 701-234-6161
Principal Investigator: Preston D. Steen
United States, Ohio
Cleveland Clinic Akron General	Recruiting
Akron, Ohio, United States, 44307
Contact: Mitchel L. Fromm 330-344-6348
Principal Investigator: Mitchel L. Fromm
UHHS-Chagrin Highlands Medical Center	Recruiting
Beachwood, Ohio, United States, 44122
Contact: Mitchell Machtay 216-844-1374
Principal Investigator: Mitchell Machtay
Geauga Hospital	Recruiting
Chardon, Ohio, United States, 44024
Contact: Mitchell Machtay 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Mitchell Machtay
University of Cincinnati/Barrett Cancer Center	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Kevin P. Redmond 513-558-4553 uchealthnews@uc.edu
Principal Investigator: Kevin P. Redmond
Case Western Reserve University	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mitchell Machtay 800-641-2422
Principal Investigator: Mitchell Machtay
Cleveland Clinic Cancer Center/Fairview Hospital	Recruiting
Cleveland, Ohio, United States, 44111
Contact: Samuel T. Chao 216-476-9362
Principal Investigator: Samuel T. Chao
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Samuel T. Chao 866-223-8100
Principal Investigator: Samuel T. Chao
Ohio State University Comprehensive Cancer Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Arnab Chakravarti 800-293-5066 Jamesline@osumc.edu
Principal Investigator: Arnab Chakravarti
Riverside Methodist Hospital	Active, not recruiting
Columbus, Ohio, United States, 43214
Mercy Cancer Center-Elyria	Recruiting
Elyria, Ohio, United States, 44035
Contact: Mitchell Machtay 440-324-0400
Principal Investigator: Mitchell Machtay
Cleveland Clinic Cancer Center Independence	Recruiting
Independence, Ohio, United States, 44131
Contact: Samuel T. Chao 800-544-6333
Principal Investigator: Samuel T. Chao
Hillcrest Hospital Cancer Center	Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Samuel T. Chao 440-312-4293 hugneyc@cchseast.org
Principal Investigator: Samuel T. Chao
Lake University Ireland Cancer Center	Recruiting
Mentor, Ohio, United States, 44060
Contact: Mitchell Machtay 440-205-5491
Principal Investigator: Mitchell Machtay
Southwest General Health Center Ireland Cancer Center	Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Mitchell Machtay 440-816-5050
Principal Investigator: Mitchell Machtay
University Hospitals Parma Medical Center	Recruiting
Parma, Ohio, United States, 44129
Contact: Mitchell Machtay 440-743-4747
Principal Investigator: Mitchell Machtay
Ireland Cancer Center at Firelands Regional Medical Center	Recruiting
Sandusky, Ohio, United States, 44870
Contact: Mitchell Machtay 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Mitchell Machtay
North Coast Cancer Care	Recruiting
Sandusky, Ohio, United States, 44870
Contact: Samuel T. Chao 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Samuel T. Chao
Cleveland Clinic Cancer Center Strongsville	Recruiting
Strongsville, Ohio, United States, 44136
Contact: Samuel T. Chao 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Samuel T. Chao
University of Toledo	Recruiting
Toledo, Ohio, United States, 43614
Contact: Krishna Reddy 419-383-6583
Principal Investigator: Krishna Reddy
University Pointe	Recruiting
West Chester, Ohio, United States, 45069
Contact: Kevin P. Redmond clinicaltrials@ucphysicians.com
Principal Investigator: Kevin P. Redmond
UHHS-Westlake Medical Center	Recruiting
Westlake, Ohio, United States, 44145
Contact: Mitchell Machtay 216-844-1374
Principal Investigator: Mitchell Machtay
Cleveland Clinic Wooster Family Health and Surgery Center	Recruiting
Wooster, Ohio, United States, 44691
Contact: Samuel T. Chao 800-862-7798
Principal Investigator: Samuel T. Chao
United States, Oklahoma
University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: J. S. Thompson 405-271-8777 ou-clinical-trials@ouhsc.edu
Principal Investigator: J. S. Thompson
United States, Oregon
Willamette Valley Cancer Center	Recruiting
Eugene, Oregon, United States, 97401
Contact: Vivek S. Kavadi 541-681-4930 wade.carson@usoncology.com
Principal Investigator: Vivek S. Kavadi
Legacy Mount Hood Medical Center	Suspended
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center	Recruiting
Portland, Oregon, United States, 97210
Contact: Andrew Y. Kee 800-220-4937 cancer@lhs.org
Principal Investigator: Andrew Y. Kee
United States, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus	Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Nimisha Deb 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Nimisha Deb
Northeast Radiation Oncology Center	Recruiting
Dunmore, Pennsylvania, United States, 18512
Contact: Wenyin Shi 888-808-6762
Principal Investigator: Wenyin Shi
Ephrata Cancer Center	Recruiting
Ephrata, Pennsylvania, United States, 17522
Contact: Amit B. Shah 717-721-4840
Principal Investigator: Amit B. Shah
Adams Cancer Center	Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amit B. Shah 877-441-7957
Principal Investigator: Amit B. Shah
UPMC Pinnacle Cancer Center/Community Osteopathic Campus	Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contact: David C. Weksberg 717-724-6765 klitchfield@PINNACLEHEALTH.org
Principal Investigator: David C. Weksberg
Sechler Family Cancer Center	Recruiting
Lebanon, Pennsylvania, United States, 17042
Contact: Amit B. Shah 717-741-8303 doxenberg@wellspan.org
Principal Investigator: Amit B. Shah
University of Pennsylvania/Abramson Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robert A. Lustig 877-827-3222
Principal Investigator: Robert A. Lustig
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Wenyin Shi 215-955-6084
Principal Investigator: Wenyin Shi
Aria Health-Torresdale Campus	Recruiting
Philadelphia, Pennsylvania, United States, 19114
Contact: Wenyin Shi 215-612-5296
Principal Investigator: Wenyin Shi
Reading Hospital	Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Terrence P. Cescon 610-988-9323
Principal Investigator: Terrence P. Cescon
WellSpan Health-York Cancer Center	Recruiting
York, Pennsylvania, United States, 17403
Contact: Amit B. Shah 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
Greenville Health System Cancer Institute-Faris	Recruiting
Greenville, South Carolina, United States, 29605
Contact: David L. Grisell 864-241-6251 kwilliams8@ghs.org
Principal Investigator: David L. Grisell
Greenville Health System Cancer Institute-Eastside	Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell 864-241-6251 kwilliams8@ghs.org
Principal Investigator: David L. Grisell
Self Regional Healthcare	Active, not recruiting
Greenwood, South Carolina, United States, 29646
Greenville Health System Cancer Institute-Greer	Recruiting
Greer, South Carolina, United States, 29650
Contact: David L. Grisell 864-241-6251 kwilliams8@ghs.org
Principal Investigator: David L. Grisell
Greenville Health System Cancer Institute-Seneca	Recruiting
Seneca, South Carolina, United States, 29672
Contact: David L. Grisell 864-241-6251 kwilliams8@ghs.org
Principal Investigator: David L. Grisell
Greenville Health System Cancer Institute-Spartanburg	Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David L. Grisell 864-241-6251 kwilliams8@ghs.org
Principal Investigator: David L. Grisell
United States, South Dakota
Sanford USD Medical Center - Sioux Falls	Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Preston D. Steen 605-312-3320 OncologyClinicalTrialsSF@SanfordHealth.org
Principal Investigator: Preston D. Steen
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	Suspended
Austin, Texas, United States, 78701
Austin Cancer Centers-Central Austin	Suspended
Austin, Texas, United States, 78702
Texas Oncology-Austin Midtown	Recruiting
Austin, Texas, United States, 78705
Contact: Vivek S. Kavadi 512-421-4163
Principal Investigator: Vivek S. Kavadi
Texas Oncology - Central Austin Cancer Center	Recruiting
Austin, Texas, United States, 78731
Contact: Vivek S. Kavadi 512-427-9400
Principal Investigator: Vivek S. Kavadi
Texas Oncology - South Austin Cancer Center	Recruiting
Austin, Texas, United States, 78745
Contact: Vivek S. Kavadi 512-447-2202
Principal Investigator: Vivek S. Kavadi
Austin Cancer Centers-North	Suspended
Austin, Texas, United States, 78758
UT Southwestern/Simmons Cancer Center-Dallas	Recruiting
Dallas, Texas, United States, 75390
Contact: Robert D. Timmerman 214-648-7097
Principal Investigator: Robert D. Timmerman
Texas Oncology-Flower Mound	Recruiting
Flower Mound, Texas, United States, 75028
Contact: Vivek S. Kavadi 972-537-4100
Principal Investigator: Vivek S. Kavadi
The Klabzuba 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	Suspended
Houston, Texas, United States, 77024
M D Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Andrew J. Bishop 713-792-3245
Principal Investigator: Andrew J. Bishop
UTMB Cancer Center at Victory Lakes	Active, not recruiting
League City, Texas, United States, 77573
Covenant Medical Center-Lakeside	Recruiting
Lubbock, Texas, United States, 79410
Contact: Paul J. Anderson 806-725-8000 jaccresearch@covhs.org
Principal Investigator: Paul J. Anderson
Texas Oncology-Seton Williamson	Suspended
Round Rock, Texas, United States, 78665
Texas Oncology - Round Rock Cancer Center	Recruiting
Round Rock, Texas, United States, 78681
Contact: Vivek S. Kavadi 512-341-8724
Principal Investigator: Vivek S. Kavadi
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: Richard L. Crownover 210-450-3800 CTO@uthscsa.edu
Principal Investigator: Richard L. Crownover
Texas Cancer Center-Sherman	Recruiting
Sherman, Texas, United States, 75090
Contact: Vivek S. Kavadi 903-868-4700
Principal Investigator: Vivek S. Kavadi
Texas Oncology Cancer Center Sugar Land	Suspended
Sugar Land, Texas, United States, 77479
Tyler Cancer Center	Recruiting
Tyler, Texas, United States, 75702
Contact: Vivek S. Kavadi 903-579-9800
Principal Investigator: Vivek S. Kavadi
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	Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Dennis C. Shrieve 801-581-4477 clinical.trials@hci.utah.edu
Principal Investigator: Dennis C. Shrieve
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment	Recruiting
Berlin, Vermont, United States, 05602
Contact: Carl J. Nelson 802-225-5400
Principal Investigator: Carl J. Nelson
University of Vermont Medical Center	Recruiting
Burlington, Vermont, United States, 05401
Contact: Carl J. Nelson 802-656-4101
Principal Investigator: Carl J. Nelson
Norris Cotton Cancer Center-North	Active, not recruiting
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center	Recruiting
Richmond, Virginia, United States, 23298
Contact: Timothy J. Harris 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Timothy J. Harris
United States, Washington
ProCure Proton Therapy Center-Seattle	Suspended
Seattle, Washington, United States, 98133
Seattle Cancer Care Alliance at Northwest Hospital	Recruiting
Seattle, Washington, United States, 98133
Contact: Lia M. Halasz 855-557-0555
Principal Investigator: Lia M. Halasz
University of Washington Medical Center	Recruiting
Seattle, Washington, United States, 98195
Contact: Lia M. Halasz 800-804-8824
Principal Investigator: Lia M. Halasz
Compass Oncology Vancouver	Recruiting
Vancouver, Washington, United States, 98684
Contact: Vivek S. Kavadi 360-449-6521 susan.papenfuse@usoncology.com
Principal Investigator: Vivek S. Kavadi
Legacy Salmon Creek Hospital	Suspended
Vancouver, Washington, United States, 98686
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center	Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Jondavid Pollock 304-243-6442
Principal Investigator: Jondavid Pollock
United States, Wisconsin
Langlade Hospital and Cancer Center	Active, not recruiting
Antigo, Wisconsin, United States, 54409
Gundersen Lutheran Medical Center	Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Collin D. Driscoll 608-775-2385 cancerctr@gundersenhealth.org
Principal Investigator: Collin D. Driscoll
University of Wisconsin Hospital and Clinics	Active, not recruiting
Madison, Wisconsin, United States, 53792
Community Memorial Hospital	Recruiting
Menomonee Falls, Wisconsin, United States, 53051
Contact: Joseph A. Bovi 262-257-5100
Principal Investigator: Joseph A. Bovi
Froedtert and the Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Joseph A. Bovi 414-805-4380
Principal Investigator: Joseph A. Bovi
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
Aspirus UW Cancer Center	Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Darryl R. Barton 877-405-6866
Principal Investigator: Darryl R. Barton
Canada, British Columbia
BCCA-Vancouver Island Cancer Centre	Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Abraham S. Alexander 604-877-6010
Principal Investigator: Abraham S. Alexander
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	Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Jean-Paul Bahary 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Jean-Paul Bahary
The Research Institute of the McGill University Health Centre (MUHC)	Recruiting
Montreal, Quebec, Canada, H3H 2R9
Contact: Valerie Panet-Raymond 514-934-1934 ext 48354 evelyn.ortega@muhc.mcgill.ca
Principal Investigator: Valerie Panet-Raymond
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	NRG Oncology
ClinicalTrials.gov Identifier:	NCT02179086 History of Changes
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:	May 1, 2018
Last Verified:	April 2018

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; Dacarbazine; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents