Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
Study Details
Study Description
Brief Summary
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Detailed Description
This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A dynamic allocation procedure will be used to allocate an equal number of patients to different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of the stratification factors among arms. The stratification factors that will be used are cooperative groups (EORTC vs. all North American groups), age (≤ 50 vs. > 50), performance score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma).
The primary goal is to determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by PCV chemotherapy (RT --> PCV)(Arm A).
Secondary Goals:
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Time to Progression - To determine whether patients who receive (RT + TMZ --> TMZ) have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT --> PCV).
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Correlation between exploratory biomarkers and survival - To determine whether there is a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT promoter hypermethylation status.
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Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life.
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Toxicity - To determine the toxicity of the treatment in each arm and perform descriptive comparisons.
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Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints.
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Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e., plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific investigations.
After completion of study treatment, patients are followed every 12 weeks for 1 year, then every 4 months for 2 years and then every 6 months until progressive disease or until the end of study participation.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm A (RT, procarbazine, lomustine, vincristine) Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Radiation: radiotherapy
Drug: procarbazine
Days 8-21: 60 mg/m^2 orally
Drug: CCNU
Day 1: 110 mg/m^2 orally
Drug: vincristine
Days 8 and 29: 1.4 mg/m^2 IV
|
Experimental: Arm B (RT, temozolomide) Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity. |
Drug: concomitant temozolomide (TMZ)
75 mg/m^2, orally daily
Radiation: radiotherapy
Drug: adjuvant temozolomide (TMZ)
150 or 200 mg/m^2 orally
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [Time from study registration to time of tumor progression or death due to any cause, whichever comes first, assessed up to 16 years]
The distribution of progression free survival for Arms A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median progression free survival (PFS) will be estimated with their confidence intervals. The Cox proportional hazards model will be used to assess whether the distributions of progression survival times differ with respect to treatment regimen having adjusted for all stratification factors (cooperative groups, age, and performance score). Both non-inferiority and superiority will be tested in this trial for the primary goal and no multiple-comparison adjustment will be considered.
Secondary Outcome Measures
- Time to progression [Time from study registration to the earliest evidence of clinical progression, radiographic progression or neurocognitive progression, assessed up to 16 years]
Estimated by Kaplan-Meier method and analyzed by Cox regression model adjusting all stratification factors. Correlations among baseline neurocognitive test scores and progression free survival will be analyzed using Cox proportional hazards model.
- Time to neurocognitive progression, assessed using the Hopkins Verbal Learning Test-Revised for Free Recall, Delayed Recall, and Delayed Recognition; the Controlled Oral Word Association test; and the Trail Making Test Part A or B [Time from study registration to the first cognitive failure, assessed up to 16 years]
Estimated by Kaplan-Meier method and analyzed by Cox regression model adjusting all stratification factors. For each test in the battery, a standard error of measurement will be used to derive the Reliable Change Index (RCI) which will be used to represent the 90% confidence interval for the difference in raw scores from baseline to follow-up assessment will be coded as 1 (deterioration), 2 (no change), and 3 (improved) according to the RCI.
- Overall survival [Time from study registration to time of death due to any cause, assessed up to 16 years]
The Cox proportional hazards model will be used to assess whether the distributions of overall survival times differ with respect to treatment regimen having adjusted for all stratification factors (cooperative groups, age, and Performance Score). The distribution of overall survival for Arm A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median survivals will be estimated with their 95% confidence intervals.
- Objective tumor response defined as a complete response or partial response [Up to 16 years]
Summarized for each arm and compared between the arms using the Chi square test.
- Treatment-related adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [Up to 16 years]
The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. Adverse events and treatment-related adverse events will be evaluated using all patients. Treatment-related adverse events will be tabulated for each arm.
Eligibility Criteria
Criteria
Pre-Registration Inclusion Criteria:
- United States (US) and Canadian sites:
- This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible
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Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review
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Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility, the 1p/19q analysis results will be accepted from the local site, as determined by either a locally available or reference laboratory (for US, must be Clinical Laboratory Improvement Act [CLIA] certified); acceptable methods for determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by genomic sequencing or methylomic analyses; US and Canadian sites must send a copy of the official report to the pathology coordinator and quality assurance specialist (QAS)
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Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses; this should be performed at the local site (US: performed in a CLIA certified laboratory); the site must send a copy of the official report to the pathology coordinator and QAS
Registration Inclusion Criteria:
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Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy
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Histological evidence of World Health Organization (WHO) grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study
- Note: mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q
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Patients with codeleted low grade gliomas must also be considered "high risk" by exhibiting one or more of the following characteristics:
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Age >= 40 and any surgical therapy
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Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)
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Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy)
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Intractable seizures
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Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery
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Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to registration
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Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration
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Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration
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Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration
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Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN obtained =< 21 days prior to registration
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Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration
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Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
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Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
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Written informed consent
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Willingness to return to enrolling institution for follow-up during the active monitoring phase (that is, the active treatment and observation portion) of the study); patients who have been formally transferred to another active and approved site participating in this study would not need to return to the enrolling institution for this purpose
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Willingness to allow the provision of tissue samples for correlative research, as long as adequate tissues are available; patients will not be excluded from participation in the study, if they are willing to allow provision of tissues for the correlative research, but there are insufficient quantities of tissue for the correlative analyses (e.g., a patient otherwise eligible and willing who had biopsy only) Willingness to allow the provision of blood samples for correlative research; patients are not excluded from participation in the study, if they are willing to provide the mandatory biospecimens for translational/correlative research, but for logistical reasons the specimens(s) were not obtainable or if the volume collected was insufficient
Registration Exclusion Criteria:
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The following categories are ineligible:
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Pregnant women
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Nursing women
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Men or women of childbearing potential who are unwilling to employ adequate contraception or contraceptive method during this study and 6 months following the completion of chemotherapy treatments
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History of prior radiation therapy or chemotherapy for glioma; note: patients who have a history of prior low grade glioma (with or without a distant history of prior surgery for that glioma), but who have never received prior chemotherapy or radiation therapy for the glioma are eligible for the study
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Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
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Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study
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Patients known to be human immunodeficiency virus (HIV) positive and currently receiving retroviral therapy are not eligible; note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study
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Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm
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Other active malignancy within 5 years of registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, the patient is not eligible if they are receiving other specific treatment (with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if they have received prior total body irradiation which included the brain
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History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
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Recent history of hepatitis infection or if the treating physician determined that the patient would be at significant risk of reactivation of hepatitis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
2 | Providence Hospital | Mobile | Alabama | United States | 36608 |
3 | Anchorage Associates in Radiation Medicine | Anchorage | Alaska | United States | 98508 |
4 | Alaska Oncology and Hematology LLC | Anchorage | Alaska | United States | 99508 |
5 | Alaska Women's Cancer Care | Anchorage | Alaska | United States | 99508 |
6 | Anchorage Oncology Centre | Anchorage | Alaska | United States | 99508 |
7 | Katmai Oncology Group | Anchorage | Alaska | United States | 99508 |
8 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
9 | Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | United States | 85013 |
10 | Arizona Oncology-Deer Valley Center | Phoenix | Arizona | United States | 85027 |
11 | Arizona Oncology Services Foundation | Scottsdale | Arizona | United States | 85260 |
12 | Kaiser Permanente-Anaheim | Anaheim | California | United States | 92806 |
13 | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | United States | 95603 |
14 | Mills-Peninsula Medical Center | Burlingame | California | United States | 94010 |
15 | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | United States | 95682 |
16 | Community Cancer Institute | Clovis | California | United States | 93611 |
17 | University Oncology Associates | Clovis | California | United States | 93611 |
18 | UC San Diego Moores Cancer Center | La Jolla | California | United States | 92093 |
19 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
20 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
21 | Memorial Medical Center | Modesto | California | United States | 95355 |
22 | Kaiser Permanente Oakland-Broadway | Oakland | California | United States | 94611 |
23 | Kaiser Permanente-Ontario | Ontario | California | United States | 91761 |
24 | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
25 | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | United States | 95661 |
26 | Sutter Roseville Medical Center | Roseville | California | United States | 95661 |
27 | Sutter Medical Center Sacramento | Sacramento | California | United States | 95816 |
28 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
29 | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | United States | 95051 |
30 | Kaiser Permanente-South San Francisco | South San Francisco | California | United States | 94080 |
31 | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California | United States | 95687 |
32 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
33 | The Medical Center of Aurora | Aurora | Colorado | United States | 80012 |
34 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
35 | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | United States | 80907 |
36 | UCHealth Memorial Hospital Central | Colorado Springs | Colorado | United States | 80909 |
37 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
38 | Saint Anthony Hospital | Lakewood | Colorado | United States | 80228 |
39 | Littleton Adventist Hospital | Littleton | Colorado | United States | 80122 |
40 | Longmont United Hospital | Longmont | Colorado | United States | 80501 |
41 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
42 | Parker Adventist Hospital | Parker | Colorado | United States | 80138 |
43 | Saint Mary Corwin Medical Center | Pueblo | Colorado | United States | 81004 |
44 | Yale University | New Haven | Connecticut | United States | 06520 |
45 | Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | United States | 06611 |
46 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
47 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33486 |
48 | University of Florida Health Science Center - Gainesville | Gainesville | Florida | United States | 32610 |
49 | Baptist MD Anderson Cancer Center | Jacksonville | Florida | United States | 32207 |
50 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
51 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
52 | Emory Proton Therapy Center | Atlanta | Georgia | United States | 30308 |
53 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
54 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
55 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
56 | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | United States | 83605 |
57 | Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | United States | 83854 |
58 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
59 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
60 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
61 | Centralia Oncology Clinic | Centralia | Illinois | United States | 62801 |
62 | Northwestern University | Chicago | Illinois | United States | 60611 |
63 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
64 | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | United States | 62526 |
65 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
66 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
67 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
68 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
69 | Western Illinois Cancer Treatment Center | Galesburg | Illinois | United States | 61401 |
70 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
71 | AMITA Health Adventist Medical Center | La Grange | Illinois | United States | 60525 |
72 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
73 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
74 | Cancer Care Center of O'Fallon | O'Fallon | Illinois | United States | 62269 |
75 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
76 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
77 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
78 | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | United States | 61554 |
79 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
80 | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | United States | 61615 |
81 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
82 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
83 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
84 | Valley Radiation Oncology | Peru | Illinois | United States | 61354 |
85 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
86 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
87 | Parkview Hospital Randallia | Fort Wayne | Indiana | United States | 46805 |
88 | Parkview Regional Medical Center | Fort Wayne | Indiana | United States | 46845 |
89 | Memorial Regional Cancer Center Day Road | Mishawaka | Indiana | United States | 46545 |
90 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
91 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
92 | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | United States | 50325 |
93 | Mercy Cancer Center-West Lakes | Clive | Iowa | United States | 50325 |
94 | Greater Regional Medical Center | Creston | Iowa | United States | 50801 |
95 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
96 | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | United States | 50309 |
97 | Broadlawns Medical Center | Des Moines | Iowa | United States | 50314 |
98 | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | United States | 50314 |
99 | Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
100 | Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
101 | Methodist West Hospital | West Des Moines | Iowa | United States | 50266-7700 |
102 | Mercy Medical Center-West Lakes | West Des Moines | Iowa | United States | 50266 |
103 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
104 | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | United States | 66210 |
105 | University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | United States | 66211 |
106 | University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | United States | 66205 |
107 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
108 | Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky | United States | 40202 |
109 | Norton Brownsboro Hospital and Medical Campus | Louisville | Kentucky | United States | 40241 |
110 | West Jefferson Medical Center | Marrero | Louisiana | United States | 70072 |
111 | Maine Medical Center-Bramhall Campus | Portland | Maine | United States | 04102 |
112 | Maine Medical Center- Scarborough Campus | Scarborough | Maine | United States | 04074 |
113 | Maine Medical Partners Neurology | Scarborough | Maine | United States | 04074 |
114 | Maine Medical Partners - South Portland | South Portland | Maine | United States | 04106 |
115 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
116 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
117 | Cancer Trials Support Unit | Rockville | Maryland | United States | 20850-2062 |
118 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
119 | Bixby Medical Center | Adrian | Michigan | United States | 49221 |
120 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
121 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
122 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
123 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
124 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
125 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
126 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
127 | William Beaumont Hospital - Troy | Troy | Michigan | United States | 48085 |
128 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
129 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
130 | Essentia Health Cancer Center | Duluth | Minnesota | United States | 55805 |
131 | Miller-Dwan Hospital | Duluth | Minnesota | United States | 55805 |
132 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
133 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
134 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
135 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
136 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
137 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
138 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
139 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
140 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
141 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
142 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
143 | Saint Francis Regional Medical Center | Shakopee | Minnesota | United States | 55379 |
144 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
145 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
146 | Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
147 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
148 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
149 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
150 | University of Kansas Cancer Center - North | Kansas City | Missouri | United States | 64154 |
151 | University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | United States | 64064 |
152 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
153 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
154 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
155 | Saint Vincent Healthcare | Billings | Montana | United States | 59101 |
156 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
157 | Great Falls Clinic | Great Falls | Montana | United States | 59405 |
158 | CHI Health Saint Francis | Grand Island | Nebraska | United States | 68803 |
159 | CHI Health Good Samaritan | Kearney | Nebraska | United States | 68847 |
160 | Nebraska Hematology and Oncology | Lincoln | Nebraska | United States | 68506 |
161 | Southeast Nebraska Cancer Center - 68th Street Place | Lincoln | Nebraska | United States | 68516 |
162 | Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68106 |
163 | Alegent Health Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
164 | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
165 | Nebraska Cancer Specialists - Omaha | Omaha | Nebraska | United States | 68124 |
166 | Alegent Health Lakeside Hospital | Omaha | Nebraska | United States | 68130 |
167 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
168 | Midlands Community Hospital | Papillion | Nebraska | United States | 68046 |
169 | Regional West Medical Center Cancer Center | Scottsbluff | Nebraska | United States | 69361 |
170 | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | United States | 89106 |
171 | GenesisCare USA - Las Vegas | Las Vegas | Nevada | United States | 89109 |
172 | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | United States | 89119 |
173 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89148 |
174 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
175 | Saint Mary's Regional Medical Center | Reno | Nevada | United States | 89503 |
176 | Radiation Oncology Associates | Reno | Nevada | United States | 89509 |
177 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
178 | Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
179 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
180 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
181 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
182 | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | United States | 11215 |
183 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
184 | Highland Hospital | Rochester | New York | United States | 14620 |
185 | University of Rochester | Rochester | New York | United States | 14642 |
186 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
187 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
188 | Altru Cancer Center | Grand Forks | North Dakota | United States | 58201 |
189 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
190 | MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
191 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
192 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
193 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
194 | The Mark H Zangmeister Center | Columbus | Ohio | United States | 43219 |
195 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
196 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
197 | ProMedica Flower Hospital | Sylvania | Ohio | United States | 43560 |
198 | Saint Ann's Hospital | Westerville | Ohio | United States | 43081 |
199 | Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | United States | 44691 |
200 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
201 | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | United States | 74146 |
202 | Clackamas Radiation Oncology Center | Clackamas | Oregon | United States | 97015 |
203 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
204 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
205 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
206 | Providence Saint Vincent Medical Center | Portland | Oregon | United States | 97225 |
207 | Jefferson Abington Hospital | Abington | Pennsylvania | United States | 19001 |
208 | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | United States | 18103 |
209 | Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania | United States | 18015 |
210 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
211 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
212 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
213 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
214 | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | United States | 15232 |
215 | Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
216 | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
217 | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | United States | 29316 |
218 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
219 | Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina | United States | 29601 |
220 | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | United States | 29605 |
221 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
222 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
223 | Prisma Health Cancer Institute - Greer | Greer | South Carolina | United States | 29650 |
224 | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | United States | 29672 |
225 | Spartanburg Medical Center | Spartanburg | South Carolina | United States | 29303 |
226 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
227 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
228 | Parkland Memorial Hospital | Dallas | Texas | United States | 75235 |
229 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
230 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
231 | UTMB Cancer Center at Victory Lakes | League City | Texas | United States | 77573 |
232 | Sandra L Maxwell Cancer Center | Cedar City | Utah | United States | 84720 |
233 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
234 | Utah Valley Regional Medical Center | Provo | Utah | United States | 84604 |
235 | Dixie Medical Center Regional Cancer Center | Saint George | Utah | United States | 84770 |
236 | Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah | United States | 84106 |
237 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
238 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
239 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
240 | VCU Community Memorial Health Center | South Hill | Virginia | United States | 23970 |
241 | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | United States | 98225 |
242 | Kadlec Clinic Hematology and Oncology | Kennewick | Washington | United States | 99336 |
243 | Tri-Cities Cancer Center | Kennewick | Washington | United States | 99336 |
244 | Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon | Washington | United States | 98274 |
245 | Skagit Valley Hospital | Mount Vernon | Washington | United States | 98274 |
246 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
247 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
248 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
249 | University of Washington Medical Center - Montlake | Seattle | Washington | United States | 98195 |
250 | PeaceHealth Southwest Medical Center | Vancouver | Washington | United States | 98664 |
251 | West Virginia University Healthcare | Morgantown | West Virginia | United States | 26506 |
252 | Northwest Wisconsin Cancer Center | Ashland | Wisconsin | United States | 54806 |
253 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
254 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
255 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
256 | ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | United States | 53066 |
257 | ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
258 | UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | United States | 53188 |
259 | Medical University Vienna | Vienna | Austria | A-1090 | |
260 | Alegemeen Ziekenhuis Middelheim | Antwerpen | Belgium | 2020 | |
261 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
262 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
263 | BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | Canada | V5Z 4E6 |
264 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
265 | London Regional Cancer Program | London | Ontario | Canada | N6A 4L6 |
266 | Ottawa Hospital and Cancer Center-General Campus | Ottawa | Ontario | Canada | K1H 8L6 |
267 | Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
268 | University Health Network-Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
269 | CHUM - Hopital Notre-Dame | Montreal | Quebec | Canada | H2L 4M1 |
270 | CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2X 3E4 |
271 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
272 | Centre Leon Berard | Lyon | France | 69373 | |
273 | Centre Antoine Lacassagne | Nice | France | 06189 | |
274 | Gustave Roussy | Villejuif | France | 94805 | |
275 | Academ Zienkenhuis Bij De University | Amsterdam | Netherlands | 1007 MB | |
276 | University Medical Center Groningen | Groningen | Netherlands | 9700 GZ | |
277 | Maastro Clinic-Maastricht Radiation Oncology | Maastricht | Netherlands | 6229 NA | |
278 | Erasmus University Medical Center | Rotterdam | Netherlands | 3015 CE |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
- European Organisation for Research and Treatment Center (EORTC)
- Canadian Cancer Trials Group
Investigators
- Study Chair: Kurt Jaeckle, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- N0577
- NCI-2011-01915
- EORTC-26081-22086
- EudraCT-2008-007295-14
- CDR0000640442