Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01220583
Collaborator
National Cancer Institute (NCI) (NIH), NRG Oncology (Other)
252
268
2
213
0.9
0

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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 radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors.

PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: cisplatin
  • Radiation: 3-dimensional conformal radiation therapy
  • Radiation: intensity-modulated radiation therapy
Phase 2

Detailed Description

OBJECTIVES:

Primary

Phase II

  • Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors.

  • Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

Phase III

  • Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone.

Secondary

Phase II/III

  • Compare the acute toxicities of these 2 adjuvant treatments.

  • Compare late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.

  • Compare progression-free survival rates among patients receiving cisplatin and radiation to those receiving radiation alone in both the cohort of patients with pathologically high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma, salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk disease (all other eligible diagnoses).

  • Investigate quality of life and patient-reported outcomes in patients enrolled in the study.

  • Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies.

  • Establish a NRG Oncology baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.

  • Arm II: Patients undergo 3D-CRT or IMRT as in Arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.

Drug: cisplatin
Given IV

Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy

Radiation: intensity-modulated radiation therapy
Undergo radiotherapy

Experimental: Arm II

Patients undergo 3D-CRT or IMRT as in arm I.

Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy

Radiation: intensity-modulated radiation therapy
Undergo radiotherapy

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years [From randomization to 2 years.]

Secondary Outcome Measures

  1. Overall survival (OS) rate at 2 years [From randomization to 2 years.]

  2. PFS rate at 5 years [From randomization to 5 years.]

  3. OS rate at 5 years [From randomization to 5 years.]

  4. Treatment-related toxicity, defined as any grade 3-4 adverse events (CTCAE v. 4) deemed to be definitely, probably, or possibly related to protocol treatment [From start of treatment to last follow-up.]

  5. Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment [From start of treatment to 30 days after the end of treatment.]

  6. Chemotherapy delivery as measured by percentage of protocol prescription given [From start of treatment to end of treatment.]

  7. Radiation delivery as measured by elapsed treatment days [From start of treatment to end of treatment.]

  8. Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiotherapy. [From randomization to 2 years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes:

  • Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma

  • High-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma

  • Surgical resection with curative intent within 8 weeks prior to registration

  • All patients must have a Medical Oncology evaluation within 4 weeks prior to registration

  • Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin; patients must be free of distant metastases based upon the following minimum diagnostic workup:

  • History/physical examination within 8 weeks prior to registration

  • Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required (PET/CT is acceptable)

  • No patients with residual macroscopic disease after surgery

  • No prior systemic chemotherapy or radiation therapy for salivary gland malignancy

PATIENT CHARACTERISTICS:
  • Zubrod performance status 0-1

  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3

  • Platelets ≥ 100,000 cells/mm^3

  • Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)

  • Serum creatinine < 2.0 mg/dL

  • Total bilirubin < 2 x the institutional upper limit of normal (ULN)

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN

  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential

  • Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment

  • Not pregnant or nursing

  • Patients must be deemed able to comply with the treatment plan and follow-up schedule

  • Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review

  • No 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)

  • No severe, active co-morbidity, defined as follows:

  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

  • Transmural myocardial infarction within the last 6 months

  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (coagulation parameters are not required for entry into this protocol)

  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol)

  • Protocol-specific requirements may also exclude immunocompromised patients

  • Pre-existing ≥ grade 2 neuropathy

  • No significant pre-existing hearing loss, as defined by the patient or treating physician

PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

  • No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable)

  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

  • No prior organ transplant

  • No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy

  • No concurrent erythropoiesis-stimulating agents

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
2 The Kirklin Clinic at Acton Road Birmingham Alabama United States 35243
3 Arizona Breast Cancer Specialists-Gilbert Gilbert Arizona United States 85297
4 Arizona Center for Cancer Care-Peoria Peoria Arizona United States 85381
5 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
6 Arizona Breast Cancer Specialists-Phoenix Phoenix Arizona United States 85027
7 Arizona Oncology-Deer Valley Center Phoenix Arizona United States 85027
8 Arizona Breast Cancer Specialists Scottsdale Arizona United States 85251
9 Arizona Breast Cancer Specialists-Scottsdale Scottsdale Arizona United States 85258
10 Arizona Oncology Services Foundation Scottsdale Arizona United States 85260
11 Arizona Center for Cancer Care-Surprise Surprise Arizona United States 85374
12 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
13 Banner University Medical Center - Tucson Tucson Arizona United States 85719
14 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
15 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
16 AIS Cancer Center at San Joaquin Community Hospital Bakersfield California United States 93301
17 Mills-Peninsula Medical Center Burlingame California United States 94010
18 Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California United States 95682
19 Mercy San Juan Medical Center Carmichael California United States 95608
20 City of Hope Comprehensive Cancer Center Duarte California United States 91010
21 UC San Diego Moores Cancer Center La Jolla California United States 92093
22 Los Angeles County-USC Medical Center Los Angeles California United States 90033
23 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
24 Fremont - Rideout Cancer Center Marysville California United States 95901
25 Memorial Medical Center Modesto California United States 95355
26 Hoag Memorial Hospital Newport Beach California United States 92663
27 Saint Joseph Hospital - Orange Orange California United States 92868
28 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
29 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
30 Sutter Medical Center Sacramento Sacramento California United States 95816
31 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
32 UCSF Medical Center-Mount Zion San Francisco California United States 94115
33 UCSF Medical Center-Mission Bay San Francisco California United States 94158
34 Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California United States 95687
35 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
36 University of Colorado Hospital Aurora Colorado United States 80045
37 Boulder Community Hospital Boulder Colorado United States 80301
38 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
39 Porter Adventist Hospital Denver Colorado United States 80210
40 Swedish Medical Center Englewood Colorado United States 80113
41 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
42 Longmont United Hospital Longmont Colorado United States 80501
43 McKee Medical Center Loveland Colorado United States 80539
44 North Suburban Medical Center Thornton Colorado United States 80229
45 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
46 William Backus Hospital Norwich Connecticut United States 06360
47 Helen F Graham Cancer Center Newark Delaware United States 19713
48 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
49 Beebe Health Campus Rehoboth Beach Delaware United States 19971
50 UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida United States 33146
51 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
52 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
53 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
54 University of Florida Health Science Center - Jacksonville Jacksonville Florida United States 32209
55 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
56 Miami Cancer Institute Miami Florida United States 33176
57 Orlando Health Cancer Institute Orlando Florida United States 32806
58 Moffitt Cancer Center Tampa Florida United States 33612
59 Emory Proton Therapy Center Atlanta Georgia United States 30308
60 Emory University Hospital Midtown Atlanta Georgia United States 30308
61 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
62 Memorial Health University Medical Center Savannah Georgia United States 31404
63 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
64 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
65 Northwestern University Chicago Illinois United States 60611
66 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612
67 Loyola University Medical Center Maywood Illinois United States 60153
68 Saint John's Hospital Springfield Illinois United States 62702
69 IU Health North Hospital Carmel Indiana United States 46032
70 Goshen Center for Cancer Care Goshen Indiana United States 46526
71 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
72 Sidney and Lois Eskenazi Hospital Indianapolis Indiana United States 46202
73 Memorial Hospital of South Bend South Bend Indiana United States 46601
74 McFarland Clinic PC - Ames Ames Iowa United States 50010
75 Iowa Methodist Medical Center Des Moines Iowa United States 50309
76 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
77 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
78 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
79 University of Kansas Cancer Center Kansas City Kansas United States 66160
80 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
81 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
82 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
83 University Medical Center New Orleans New Orleans Louisiana United States 70112
84 Touro Infirmary New Orleans Louisiana United States 70115
85 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
86 Greater Baltimore Medical Center Baltimore Maryland United States 21204
87 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
88 Boston Medical Center Boston Massachusetts United States 02118
89 Bixby Medical Center Adrian Michigan United States 49221
90 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
91 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
92 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
93 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
94 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
95 Henry Ford Hospital Detroit Michigan United States 48202
96 Ascension Saint John Hospital Detroit Michigan United States 48236
97 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
98 Genesys Hurley Cancer Institute Flint Michigan United States 48503
99 West Michigan Cancer Center Kalamazoo Michigan United States 49007
100 Saint Mary Mercy Hospital Livonia Michigan United States 48154
101 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
102 Lake Huron Medical Center Port Huron Michigan United States 48060
103 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
104 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
105 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
106 Mayo Clinic in Rochester Rochester Minnesota United States 55905
107 University of Mississippi Medical Center Jackson Mississippi United States 39216
108 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
109 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
110 Freeman Health System Joplin Missouri United States 64804
111 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
112 SSM Health Saint Louis University Hospital Saint Louis Missouri United States 63104
113 Washington University School of Medicine Saint Louis Missouri United States 63110
114 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
115 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
116 Mercy Hospital Springfield Springfield Missouri United States 65804
117 Billings Clinic Cancer Center Billings Montana United States 59101
118 Bozeman Deaconess Hospital Bozeman Montana United States 59715
119 Kalispell Regional Medical Center Kalispell Montana United States 59901
120 Nebraska Methodist Hospital Omaha Nebraska United States 68114
121 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
122 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
123 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
124 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
125 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
126 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
127 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
128 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
129 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
130 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
131 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
132 Virtua Memorial Mount Holly New Jersey United States 08060
133 Rutgers New Jersey Medical School Newark New Jersey United States 07101
134 Sparta Cancer Treatment Center Sparta New Jersey United States 07871
135 Virtua Voorhees Voorhees New Jersey United States 08043
136 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
137 Northwell Health Imbert Cancer Center Bay Shore New York United States 11706
138 Maimonides Medical Center Brooklyn New York United States 11219
139 Memorial Sloan Kettering Commack Commack New York United States 11725
140 Memorial Sloan Kettering Westchester Harrison New York United States 10604
141 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
142 Long Island Jewish Medical Center New Hyde Park New York United States 11040
143 Mount Sinai Union Square New York New York United States 10003
144 Mount Sinai Chelsea New York New York United States 10011
145 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
146 Lenox Hill Hospital New York New York United States 10021
147 Mount Sinai Hospital New York New York United States 10029
148 Memorial Sloan Kettering Cancer Center New York New York United States 10065
149 Highland Hospital Rochester New York United States 14620
150 University of Rochester Rochester New York United States 14642
151 Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow New York United States 10591
152 State University of New York Upstate Medical University Syracuse New York United States 13210
153 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
154 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
155 Duke University Medical Center Durham North Carolina United States 27710
156 Summa Health System - Akron Campus Akron Ohio United States 44304
157 Summa Health System - Barberton Campus Barberton Ohio United States 44203
158 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
159 Case Western Reserve University Cleveland Ohio United States 44106
160 Cleveland Clinic Foundation Cleveland Ohio United States 44195
161 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
162 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
163 Summa Health Medina Medical Center Medina Ohio United States 44256
164 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
165 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
166 University Hospitals Parma Medical Center Parma Ohio United States 44129
167 UH Seidman Cancer Center at Salem Regional Medical Center Salem Ohio United States 44460
168 UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
169 ProMedica Flower Hospital Sylvania Ohio United States 43560
170 University of Toledo Toledo Ohio United States 43614
171 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
172 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
173 Cancer Treatment Center Wooster Ohio United States 44691
174 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
175 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
176 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
177 Providence Portland Medical Center Portland Oregon United States 97213
178 Providence Saint Vincent Medical Center Portland Oregon United States 97225
179 Oregon Health and Science University Portland Oregon United States 97239
180 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
181 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
182 Geisinger Medical Center Danville Pennsylvania United States 17822
183 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
184 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
185 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
186 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
187 Lewistown Hospital Lewistown Pennsylvania United States 17044
188 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
189 UPMC Jameson New Castle Pennsylvania United States 16105
190 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
191 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
192 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
193 Temple University Hospital Philadelphia Pennsylvania United States 19140
194 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
195 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
196 UPMC Jefferson Regional Radiation Oncology Pittsburgh Pennsylvania United States 15236
197 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
198 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
199 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
200 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
201 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
202 Medical University of South Carolina Charleston South Carolina United States 29425
203 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
204 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
205 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
206 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
207 Rapid City Regional Hospital Rapid City South Dakota United States 57701
208 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
209 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
210 MD Anderson in The Woodlands Conroe Texas United States 77384
211 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
212 M D Anderson Cancer Center Houston Texas United States 77030
213 MD Anderson West Houston Houston Texas United States 77079
214 MD Anderson League City League City Texas United States 77573
215 MD Anderson in Sugar Land Sugar Land Texas United States 77478
216 American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah United States 84003
217 Sandra L Maxwell Cancer Center Cedar City Utah United States 84720
218 Logan Regional Hospital Logan Utah United States 84321
219 Intermountain Medical Center Murray Utah United States 84107
220 Utah Valley Regional Medical Center Provo Utah United States 84604
221 Dixie Medical Center Regional Cancer Center Saint George Utah United States 84770
222 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
223 Norris Cotton Cancer Center-North Saint Johnsbury Vermont United States 05819
224 Inova Schar Cancer Institute Fairfax Virginia United States 22031
225 Inova Fairfax Hospital Falls Church Virginia United States 22042
226 Sentara Cancer Institute at Sentara CarePlex Hospital Hampton Virginia United States 23666
227 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
228 Sentara Virginia Beach General Hospital Virginia Beach Virginia United States 23454
229 Saint Francis Hospital Federal Way Washington United States 98003
230 Seattle Cancer Care Alliance at Northwest Hospital Seattle Washington United States 98133
231 University of Washington Medical Center - Montlake Seattle Washington United States 98195
232 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
233 Compass Oncology Vancouver Vancouver Washington United States 98684
234 West Virginia University Healthcare Morgantown West Virginia United States 26506
235 Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia United States 26003
236 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
237 Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin United States 54937
238 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
239 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
240 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
241 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
242 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
243 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
244 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
245 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
246 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
247 Bay Area Medical Center Marinette Wisconsin United States 54143
248 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
249 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
250 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
251 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
252 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
253 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
254 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495
255 Aurora Medical Center in Summit Summit Wisconsin United States 53066
256 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
257 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
258 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
259 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
260 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
261 London Regional Cancer Program London Ontario Canada N6A 4L6
262 Health Sciences North Sudbury Ontario Canada P3E 5J1
263 University Health Network-Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
264 CHUM - Hopital Notre-Dame Montreal Quebec Canada H2L 4M1
265 McGill University Department of Oncology Montreal Quebec Canada H2W 1S6
266 CHUM - Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2X 3E4
267 The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec Canada H3H 2R9
268 King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia 11211

Sponsors and Collaborators

  • Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • NRG Oncology

Investigators

  • Principal Investigator: Cristina P. Rodriguez, MD, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01220583
Other Study ID Numbers:
  • RTOG-1008
  • CDR0000686072
  • NCI-2013-00370
First Posted:
Oct 14, 2010
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022

Study Results

No Results Posted as of Apr 8, 2022