Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT00887146
Collaborator
National Cancer Institute (NCI) (NIH), European Organisation for Research and Treatment Center (EORTC) (Other), Canadian Cancer Trials Group (Other)
360
278
2
1.3

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
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:
  1. 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).

  2. 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.

  3. 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.

  4. Toxicity - To determine the toxicity of the treatment in each arm and perform descriptive comparisons.

  5. 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.

  6. 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

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
Actual Study Start Date :
Sep 1, 2009
Anticipated Primary Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
  • Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review

  • 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)

  • 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:
  • 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

  • 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
  • Patients with codeleted low grade gliomas must also be considered "high risk" by exhibiting one or more of the following characteristics:

  • Age >= 40 and any surgical therapy

  • Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)

  • Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy)

  • Intractable seizures

  • 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

  • Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to registration

  • Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration

  • Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration

  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration

  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN obtained =< 21 days prior to registration

  • Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration

  • Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

  • Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2

  • Written informed consent

  • 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

  • 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:
  • The following categories are ineligible:

  • Pregnant women

  • Nursing women

  • 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

  • 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

  • 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

  • Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study

  • 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

  • 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

  • Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm

  • 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

  • History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

  • 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
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.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00887146
Other Study ID Numbers:
  • N0577
  • NCI-2011-01915
  • EORTC-26081-22086
  • EudraCT-2008-007295-14
  • CDR0000640442
First Posted:
Apr 23, 2009
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022

Study Results

No Results Posted as of Mar 24, 2022