Trial record 1 of 1 for:
NRG BN-001
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02179086 |
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Recruitment Status :
Recruiting
First Posted : July 1, 2014
Last Update Posted : November 5, 2018
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Sponsor:
NRG Oncology
Collaborators:
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
NRG Oncology
- Study Details
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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 |
Show Detailed Description
| 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Temozolomide
| 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:
Radiation: intensity-modulated radiation therapy Undergo standard-dose IMRT
Other Name: IMRT Drug: temozolomide Given PO
Other Names:
Other: laboratory biomarker analysis Correlative studies |
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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:
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:
Radiation: intensity-modulated radiation therapy Undergo standard-dose IMRT
Other Name: IMRT Drug: temozolomide Given PO
Other Names:
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:
Other: laboratory biomarker analysis Correlative studies |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
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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
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179086
Hide Study 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 | |
| The University of Arizona Medical Center-University Campus | Suspended |
| Tucson, Arizona, United States, 85724 | |
| 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 | |
| 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 | Suspended |
| 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 | Recruiting |
| Jacksonville, Florida, United States, 32209 | |
| Contact: Site Public Contact 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 | Suspended |
| Atlanta, Georgia, United States, 30322 | |
| 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 | Suspended |
| 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 | Suspended |
| 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 | Suspended |
| Fort Wayne, Indiana, United States, 46805 | |
| 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 | 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 | 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 | Recruiting |
| Shreveport, Louisiana, United States, 71103 | |
| Contact: Site Public Contact 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: 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 | |
| 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 | |
| Tate Cancer Center | Suspended |
| Glen Burnie, Maryland, United States, 21061 | |
| United States, Massachusetts | |
| Tufts Medical Center | Suspended |
| 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 | |
| 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 | 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 | |
| Lakeland Medical Center Saint Joseph | Active, not recruiting |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Minnesota | |
| Sanford Clinic North-Bemidgi | Suspended |
| Bemidji, Minnesota, United States, 56601 | |
| Saint Luke's Hospital of Duluth | Suspended |
| Duluth, Minnesota, United States, 55805 | |
| 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 | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Site Public Contact 732-235-8675 | |
| Principal Investigator: Rahul R. Parikh | |
| Rutgers Cancer Institute of New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Site Public Contact 732-235-8675 | |
| Principal Investigator: Rahul R. Parikh | |
| Capital Health Medical Center-Hopewell | Suspended |
| 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 | |
| Columbia University/Herbert Irving Cancer Center | Active, not recruiting |
| New York, New York, United States, 10032 | |
| Memorial Sloan Kettering Cancer Center | Suspended |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Mission Hospital Inc-Memorial Campus | Suspended |
| 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 | Suspended |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Sanford Bismarck Medical Center | Suspended |
| Bismarck, North Dakota, United States, 58501 | |
| 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 | Suspended |
| Chardon, Ohio, United States, 44024 | |
| 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 | Suspended |
| Columbus, Ohio, United States, 43210 | |
| Riverside Methodist Hospital | Active, not recruiting |
| Columbus, Ohio, United States, 43214 | |
| Mercy Cancer Center-Elyria | Suspended |
| Elyria, Ohio, United States, 44035 | |
| Cleveland Clinic Cancer Center Independence | Suspended |
| Independence, Ohio, United States, 44131 | |
| Hillcrest Hospital Cancer Center | Suspended |
| Mayfield Heights, Ohio, United States, 44124 | |
| Lake University Ireland Cancer Center | Suspended |
| Mentor, Ohio, United States, 44060 | |
| Southwest General Health Center Ireland Cancer Center | Suspended |
| Middleburg Heights, Ohio, United States, 44130 | |
| University Hospitals Parma Medical Center | Suspended |
| Parma, Ohio, United States, 44129 | |
| Ireland Cancer Center at Firelands Regional Medical Center | Suspended |
| Sandusky, Ohio, United States, 44870 | |
| North Coast Cancer Care | Suspended |
| Sandusky, Ohio, United States, 44870 | |
| 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 | Suspended |
| Westlake, Ohio, United States, 44145 | |
| Cleveland Clinic Wooster Family Health and Surgery Center | Suspended |
| Wooster, Ohio, United States, 44691 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Suspended |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Willamette Valley Cancer Center | Suspended |
| Eugene, Oregon, United States, 97401 | |
| Legacy Mount Hood Medical Center | Suspended |
| Gresham, Oregon, United States, 97030 | |
| Legacy Good Samaritan Hospital and Medical Center | Suspended |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Saint Luke's University Hospital-Bethlehem Campus | Suspended |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Northeast Radiation Oncology Center | Suspended |
| Dunmore, Pennsylvania, United States, 18512 | |
| Ephrata Cancer Center | Suspended |
| Ephrata, Pennsylvania, United States, 17522 | |
| 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 | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Site Public Contact 800-474-9892 | |
| Principal Investigator: Robert A. Lustig | |
| 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 | |
| Greenville Health System Cancer Institute-Faris | Suspended |
| Greenville, South Carolina, United States, 29605 | |
| Greenville Health System Cancer Institute-Eastside | Suspended |
| Greenville, South Carolina, United States, 29615 | |
| Self Regional Healthcare | Active, not recruiting |
| Greenwood, South Carolina, United States, 29646 | |
| Greenville Health System Cancer Institute-Greer | Suspended |
| Greer, South Carolina, United States, 29650 | |
| Greenville Health System Cancer Institute-Seneca | Suspended |
| Seneca, South Carolina, United States, 29672 | |
| Greenville Health System 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 | Recruiting |
| Austin, Texas, United States, 78701 | |
| Contact: Site Public Contact 512-324-7991 | |
| Principal Investigator: Brian D. Vaillant | |
| Austin Cancer Centers-Central Austin | Recruiting |
| Austin, Texas, United States, 78702 | |
| Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org | |
| Principal Investigator: Brian D. Vaillant | |
| 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 | Suspended |
| Dallas, Texas, United States, 75390 | |
| Texas Oncology-Flower Mound | Recruiting |
| Flower Mound, Texas, United States, 75028 | |
| Contact: Site Public Contact 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 | Active, not recruiting |
| Houston, Texas, United States, 77024 | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Site Public Contact 877-312-3961 | |
| Principal Investigator: Andrew J. Bishop | |
| UTMB Cancer Center at Victory Lakes | Active, not recruiting |
| League City, Texas, United States, 77573 | |
| Covenant Medical Center-Lakeside | Suspended |
| 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 | |
| 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: 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 | Suspended |
| 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 | |
| Community Memorial Hospital | Suspended |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| Froedtert and the 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 |
| 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 Key Record Dates |
| Last Update Posted: | November 5, 2018 |
| Last Verified: | November 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 |