Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01546987
Collaborator
National Cancer Institute (NCI) (NIH), NRG Oncology (Other)
239
172
2
205
1.4
0

Study Details

Study Description

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the difference in overall survival of patients with clinically localized prostate cancer with unfavorable prognostic features between a) standard treatment (androgen-deprivation therapy [ADT] + radiotherapy) and b) standard treatment with the addition of 24 months of steroid 17alpha-monooxygenase TAK-700 (TAK-700).

Secondary

  • To characterize differences between the treatment groups with respect to incidence of unexpected grade ≥ 3 adverse events and/or clinically significant decrement in patient-reported quality of life (QOL) among subjects treated with TAK-700.

  • To compare rates and cumulative incidence of biochemical control (freedom from PSA failure), local/regional progression, and distant metastases.

  • To compare rate and cumulative incidence of clinical failure, defined as prostate-specific antigen (PSA) > 25 ng/mL, documented local disease progression, regional or distant metastasis, or initiation of ADT.

  • To compare prostate cancer-specific survival and other-cause mortality.

  • To compare the change in severity of fatigue as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue short form.

  • To compare changes in patient-reported QOL as measured by Expanded Prostate Cancer Index Composite (EPIC).

  • To assess quality-adjusted survival using the EQ-5D.

  • To compare nadir and average serum testosterone at 12 and 24 months during treatment.

  • To compare changes in hemoglobin A1C, fasting glucose, and fasting insulin during 24 months of systemic treatment and during the first three years of follow-up.

  • To compare changes in fasting lipid levels during 24 months of treatment and during the first three years of follow-up.

  • To compare changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up.

  • To compare the incidence of adverse events ascertained via CTCAE version 4.

  • To compare the rate of recovery of testosterone to > 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up.

  • To compare the median time to recovery of testosterone to > 230 ng/dL during the first five years of follow-up.

  • To assess cumulative incidence of relevant clinical survivorship endpoints including new diagnosis of type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, or osteoporotic fracture.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to risk group (see Disease Characteristics) and type of radiation therapy (RT) boost (intensity-modulated RT (IMRT) vs brachytherapy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive standard androgen suppression (AS) with a luteinizing hormone-releasing hormone (LHRH) agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 24 months from initiation and oral (PO) antiandrogen (such as flutamide or bicalutamide) beginning 2 months prior and for the duration of radiation therapy (RT).

  • Arm II: Patients receive the same standard AS with LHRH agonist and oral antiandrogen as in arm 1. Patients also receive steroid 17alpha-monooxygenase TAK-700 (TAK-700) PO twice daily (BID) for 2 years.

In both arms, patients undergo IMRT or 3D-conformal RT to the whole pelvis once daily, 5 days a week, for 6-8 weeks. Some patients also receive brachytherapy.

Quality of life is assessed via the Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Scale, the Expanded Prostate Cancer Index Composite (EPIC-26), and the EuroQol (EQ-5D) assessments at baseline and periodically during the study.

Serum may be collected from some patients for correlative studies.

After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
239 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) With a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT With a GNRH Agonist and TAK-700 For Men With High Risk Prostate Cancer
Actual Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Jun 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ADT + GnRH agonist + dose escalated radiation

Patients receive standard androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 24 months from initiation and oral (PO) antiandrogen (such as flutamide or bicalutamide) beginning 2 months prior and for the duration of radiation therapy (RT).

Drug: bicalutamide
Given orally

Drug: buserelin
Given subcutaneously or intramuscularly

Drug: flutamide
Given orally

Drug: goserelin acetate
Given subcutaneously or intramuscularly

Drug: leuprolide acetate
Given subcutaneously or intramuscularly

Drug: triptorelin
Given subcutaneously or intramuscularly

Experimental: ADT + GnRH agonist + dose escalated radiation + TAK-700

Patients receive the same standard ADT with a GnRH agonist and oral antiandrogen. In addition, patients also receive steroid 17alpha-monooxygenase TAK-700 (TAK-700) PO twice daily (BID) for 2 years.

Drug: bicalutamide
Given orally

Drug: buserelin
Given subcutaneously or intramuscularly

Drug: flutamide
Given orally

Drug: goserelin acetate
Given subcutaneously or intramuscularly

Drug: leuprolide acetate
Given subcutaneously or intramuscularly

Drug: orteronel
Given orally

Drug: triptorelin
Given subcutaneously or intramuscularly

Outcome Measures

Primary Outcome Measures

  1. Overall survival [From the date of randomization to the date of death due to any cause.]

Secondary Outcome Measures

  1. Incidence of unexpected grade ≥ 3 adverse events and/or clinically significant decrement in patient-reported quality of life (PR-QOL) among patients treated with TAK-700 [From the date of randomization to the date of first documented AE ≥ grade 3 and/or to the date of first clinically significant decrement in patient-reported quality of life (PR-QOL) among patients treated with TAK-700.]

  2. Rates and cumulative incidence of biochemical control - freedom from PSA failure [From the date of randomization to the date of first documented biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA) or the initiation of salvage androgen deprivation therapy.]

  3. General clinical treatment failure-free interval [From the date of randomization to the date of first documented general clinical treatment failure defined as: PSA > 25 ng/ml or documented local disease progression or regional or distant metastasis or initiation of androgen deprivation therapy.]

  4. Prostate cancer-specific survival and other-cause survival [From the date of randomization to the date of death due to prostate cancer for prostate cancer-specific survival and to the date of death due to other causes for other-cause survival.]

  5. Change in fatigue from baseline to 1 year, as measured by PROMIS [One year from the date of randomization.]

  6. Changes in PR-QOL as measured by EPIC [From the date of randomization to the week prior to RT start, to the last week of RT and 1 year and 2.5 years after the initiation of therapy.]

  7. Assessment of quality-adjusted survival using the EQ-5D [From the date of randomization to the week prior to RT start, to the last week of RT and 1 year and 2.5 years after the initiation of therapy.]

  8. Nadir and average serum testosterone at 12 and 24 months during treatment [From baseline to 12 months and 24 months of treatment.]

  9. Lipid profiles at 12 and 24 months [From baseline to 12 months and 24 months.]

  10. Fasting plasma glucose, fasting plasma insulin, and hemoglobin A1c at 12 and 24 months [From baseline to 12 months and 24 months.]

  11. Changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up [From baseline to 2 years from the start of treatment and after that every year for 3 more years.]

  12. Incidence of adverse events ascertained via Common Toxicity Criteria for Adverse Effects (CTCAE) version 4 [From the start of therapy to 6 months of follow-up.]

  13. Rate of recovery of testosterone to > 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up [From the treatment end date to the date when testosterone levels first recovered to > 230 ng/dl within 12 months and 24 months of treatment.]

  14. Median time to recovery of testosterone to > 230 ng/dL during the first five years of follow-up [From the date of ranomization to the post-treatment end date when testosterone levels first recovered to > 230 ng/dl within 5 years after treatment.]

  15. Cumulative incidence of relevant clinical survivorship endpoints including new diagnosis of type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, or osteoporotic fracture [From the date of randomization to the date of first reported new incidence of any of the above mentioned clinical endpoints.]

  16. Rates and cumulative incidence of local/regional progression [From the date of randomization to the date of the documented presence of local/regional recurrence.]

  17. Rates and cumulative incidence of distant metastases [From the date of randomization to the date of documented distant recurrence.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations (risk group):

  • Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage

  • GS ≥ 8, PSA < 20 ng/mL, T stage ≥ T2

  • GS ≥ 8, PSA ≥ 20-150 ng/mL, any T stage

  • GS ≥ 7, PSA ≥ 20-150 ng/mL, any T stage

  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) agonist or antiandrogen therapy, within 180 days of randomization

  • Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethyl- stilbestrol [DES]), or surgical castration (orchiectomy), may have been started prior to registration, provided that registration is within 50 days of beginning ADT; please note: if the patient has started ADT he will not be eligible to participate in the quality of life component of this study

  • Clinically negative lymph nodes as established by imaging (abdominal and/or pelvic CT or abdominal and/or pelvic MRI), nodal sampling, or dissection within 90 days prior to registration

  • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 2.0 cm

  • No distant metastases (M0) on bone scan within 90 days prior to registration

  • Equivocal bone scan findings are allowed if plain films are negative for metastasis

  • No definite evidence of metastatic disease

  • Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score ≤ 15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP)

  • Prior TURP is permitted for patients who receive external-beam radiotherapy (EBRT) only

PATIENT CHARACTERISTICS:
  • Height, weight, 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 Hgb ≥ 8.0 g/dL is acceptable)

  • Serum creatinine < 2.0 mg/dL

  • Creatinine clearance > 40 mL/minute

  • Bilirubin < 1.5 x upper limit of normal (ULN)

  • Alanine aminotranserase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN

  • No PSA > 150 ng/mL

  • Screening calculated ejection fraction ≥ ULN by multiple-gated acquisition (MUGA) scan or by echocardiogram

  • Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy) may have been started prior to registration, provided that registration is within 50 days of beginning ADT.

  • Patients, even if surgically sterilized (i.e., status post vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and for 4 months (120 days) after the last dose of study drug

  • No prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years

  • No known hypersensitivity to TAK-700 or related compounds

  • No history of adrenal insufficiency

  • No history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (NCI CTCAE, version 4.02) thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to registration

  • Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed

  • No New York Heart Association Class III or IV heart failure

  • No ECG abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening, or corrected QT (QTc) interval > 460 msec

  • No prior allergic reaction to the drugs involved in this protocol

  • No Cushing syndrome

  • No severe chronic renal disease or chronic liver disease

  • No uncontrolled hypertension despite appropriate medical therapy within 21 days prior to registration (blood pressure of greater than 150 mm Hg systolic and 90 mm Hg diastolic at 2 separate measurements no more than 60 minutes apart during screening visit)

  • No serious infection within 14 days prior to registration

  • No uncontrolled nausea, vomiting, or diarrhea (CTCAE grade ≥ 3) despite appropriate medical therapy at the time of registration

  • No known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

  • Prior testosterone administration is allowed if last administered at least 90 days prior to registration

  • No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason

  • No prior systemic chemotherapy for prostate cancer

  • Prior chemotherapy for a different cancer is allowed

  • No prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields

  • No previous hormonal therapy for > 50 days

  • No chronic treatment with glucocorticoids within one year

  • No major surgery within 14 days prior to registration

  • No other investigational agent

  • No other anticancer therapy

  • No concurrent hormonal therapies including estrogens or herbal products

  • No concurrent ketoconazole or aminoglutethimide

  • No chronic use of systemic corticosteroids, such as oral prednisone

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Kirklin Clinic at Acton Road Birmingham Alabama United States 35243
2 University of Alabama at Birmingham Birmingham Alabama United States 35294
3 Arizona Oncology-Deer Valley Center Phoenix Arizona United States 85027
4 Arizona Oncology Services Foundation Scottsdale Arizona United States 85260
5 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
6 Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California United States 95682
7 Mercy San Juan Medical Center Carmichael California United States 95608
8 Veterans Administration Long Beach Medical Center Long Beach California United States 90822
9 Los Angeles County-USC Medical Center Los Angeles California United States 90033
10 University of Southern California/Norris Cancer Center Los Angeles California United States 90033
11 Cedars-Sinai Medical Center Los Angeles California United States 90048
12 Pomona Valley Hospital Medical Center Pomona California United States 91767
13 Rohnert Park Cancer Center Rohnert Park California United States 94928
14 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
15 Sutter General Hospital Sacramento California United States 95816
16 University of California At San Diego San Diego California United States 92103
17 UCSF-Mount Zion San Francisco California United States 94115
18 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
19 Kaiser Permanente Cancer Treatment Center South San Francisco California United States 94080
20 Stanford University Hospitals and Clinics Stanford California United States 94305
21 Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California United States 95687
22 Sutter Solano Medical Center Vallejo California United States 94589
23 University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado United States 80045
24 Poudre Valley Radiation Oncology Fort Collins Colorado United States 80528
25 Hartford Hospital Hartford Connecticut United States 06102
26 The Hospital of Central Connecticut New Britain Connecticut United States 06050
27 William Backus Hospital Norwich Connecticut United States 06360
28 Helen F Graham Cancer Center Newark Delaware United States 19713
29 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
30 University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
31 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
32 Florida Hospital Orlando Florida United States 32803
33 Grady Health System Atlanta Georgia United States 30303
34 Piedmont Hospital Atlanta Georgia United States 30309
35 Emory University/Winship Cancer Institute Atlanta Georgia United States 30322
36 Atlanta VA Medical Center Decatur Georgia United States 30033
37 Saint Joseph's-Candler Health System Savannah Georgia United States 31405
38 Queen's Medical Center Honolulu Hawaii United States 96813
39 Saint Alphonsus Regional Medical Center Boise Idaho United States 83706
40 Idaho Urologic Institute PA Meridian Idaho United States 83642
41 Weiss Memorial Hospital Chicago Illinois United States 60640
42 Decatur Memorial Hospital Decatur Illinois United States 62526
43 Hines Veterans Administration Hospital Hines Illinois United States 60141
44 Loyola University Medical Center Maywood Illinois United States 60153
45 OSF Saint Francis Medical Center Peoria Illinois United States 61637
46 Radiation Oncology Associates PC Fort Wayne Indiana United States 46804
47 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
48 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
49 University of Kansas Medical Center Kansas City Kansas United States 66160
50 Kansas City Cancer Centers-Southwest Overland Park Kansas United States 66210
51 University of Kentucky Lexington Kentucky United States 40536
52 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
53 Touro Infirmary New Orleans Louisiana United States 70115
54 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
55 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
56 Saint Agnes Hospital Baltimore Maryland United States 21229
57 Peninsula Regional Medical Center Salisbury Maryland United States 21801
58 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
59 Brigham and Women's Hospital Boston Massachusetts United States 02115
60 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
61 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
62 Saint Anne's Hospital Fall River Massachusetts United States 02721
63 Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford Massachusetts United States 01757
64 North Shore Medical Center Cancer Center Peabody Massachusetts United States 01960
65 Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth Massachusetts United States 02190
66 Bixby Medical Center Adrian Michigan United States 49221
67 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106-0995
68 University of Michigan Ann Arbor Michigan United States 48109
69 McLaren-Flint Flint Michigan United States 48532
70 West Michigan Cancer Center Kalamazoo Michigan United States 49007
71 Great Lakes Cancer Institute-Lapeer Campus Lapeer Michigan United States 48446
72 McLaren Cancer Institute-Owosso Owosso Michigan United States 48867
73 Northern Michigan Regional Hospital Petoskey Michigan United States 49770
74 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
75 William Beaumont Hospital - Troy Troy Michigan United States 48098
76 Sanford Clinic North-Bemidgi Bemidji Minnesota United States 56601
77 Saint Luke's Hospital of Duluth Duluth Minnesota United States 55805
78 Regions Hospital Saint Paul Minnesota United States 55101
79 Southeast Cancer Center Cape Girardeau Missouri United States 63703
80 Kansas City Cancer Center - South Kansas City Missouri United States 64131
81 Kansas City Cancer Centers - North Kansas City Missouri United States 64154
82 Kansas City Cancer Center-Lee's Summit Lee's Summit Missouri United States 64064
83 Washington University School of Medicine Saint Louis Missouri United States 63110
84 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
85 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
86 Barnes-Jewish West County Hospital Saint Louis Missouri United States 63141
87 Saint John's Mercy Medical Center Saint Louis Missouri United States 63141
88 Siteman Cancer Center - Saint Peters Saint Peters Missouri United States 63376
89 Mercy Hospital Springfield Springfield Missouri United States 65804
90 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
91 Nebraska Methodist Hospital Omaha Nebraska United States 68114
92 The Nebraska Medical Center Omaha Nebraska United States 68198
93 Concord Hospital Concord New Hampshire United States 03301
94 Exeter Hospital Exeter New Hampshire United States 03833
95 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
96 Elliot Hospital Manchester New Hampshire United States 03103
97 Cooper Hospital University Medical Center Camden New Jersey United States 08103
98 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
99 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
100 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
101 Sanford Medical Center-Fargo Fargo North Dakota United States 58122
102 Summa Akron City Hospital/Cooper Cancer Center Akron Ohio United States 44304
103 Akron General Medical Center Akron Ohio United States 44307
104 Summa Barberton Hospital Barberton Ohio United States 44203
105 Geaugra Hospital Chardon Ohio United States 44024
106 University of Cincinnati Cincinnati Ohio United States 45267
107 Case Western Reserve University Cleveland Ohio United States 44106
108 Cleveland Clinic Foundation Cleveland Ohio United States 44195
109 Ohio State University Medical Center Columbus Ohio United States 43210
110 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
111 Summa Health Center at Lake Medina Medina Ohio United States 44256
112 Lake University Ireland Cancer Center Mentor Ohio United States 44060
113 Southwest General Health Center Ireland Cancer Center Middleburg Heights Ohio United States 44130
114 UHHS-Chagrin Highlands Medical Center Orange Village Ohio United States 44122
115 Robinson Radiation Oncology Ravenna Ohio United States 44266
116 Ireland Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
117 Flower Hospital Sylvania Ohio United States 43560
118 UHHS-Westlake Medical Center Westlake Ohio United States 44145
119 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
120 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
121 Rogue Valley Medical Center Medford Oregon United States 97504
122 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
123 The Regional Cancer Center Erie Pennsylvania United States 16505
124 Adams Cancer Center Gettysburg Pennsylvania United States 17325
125 Cherry Tree Cancer Center Hanover Pennsylvania United States 17331
126 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
127 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
128 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
129 Temple University Hospital Philadelphia Pennsylvania United States 19140
130 Reading Hospital West Reading Pennsylvania United States 19611
131 Lankenau Hospital Wynnewood Pennsylvania United States 19096
132 WellSpan Health-York Hospital York Pennsylvania United States 17405
133 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
134 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
135 Lexington Medical Center West Columbia South Carolina United States 29169
136 Rapid City Regional Hospital Rapid City South Dakota United States 57701
137 Texas Oncology PA - Bedford Bedford Texas United States 76022
138 University of Texas Southwestern Medical Center Dallas Texas United States 75390
139 The Klabzuba Cancer Center Fort Worth Texas United States 76104
140 University of Texas Medical Branch at Galveston Galveston Texas United States 77555-0565
141 Memorial Hermann Memorial City Medical Center Houston Texas United States 77024
142 M D Anderson Cancer Center Houston Texas United States 77030
143 UTMB Cancer Center at Victory Lakes League City Texas United States 77573
144 Texas Cancer Center-Sherman Sherman Texas United States 75090
145 Texas Oncology Cancer Center Sugar Land Sugar Land Texas United States 77479
146 Intermountain Medical Center Murray Utah United States 84157
147 Dixie Medical Center Regional Cancer Center Saint George Utah United States 84770
148 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
149 Sentara Cancer Institute at Sentara CarePlex Hospital Hampton Virginia United States 23666
150 Sentara Hospitals Norfolk Virginia United States 23507
151 Oncology and Hematology Associates of Southwest Virginia Roanoke Virginia United States 24014
152 Sentara Virginia Beach General Hospital Virginia Beach Virginia United States 23454
153 Saint Francis Hospital Federal Way Washington United States 98003
154 Virginia Mason CCOP Seattle Washington United States 98101
155 Appleton Medical Center Appleton Wisconsin United States 54911
156 Saint Vincent Hospital Green Bay Wisconsin United States 54301
157 Saint Mary's Hospital Green Bay Wisconsin United States 54303
158 Gundersen Lutheran La Crosse Wisconsin United States 54601
159 Bay Area Medical Center Marinette Wisconsin United States 54143
160 Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin United States 53097
161 Columbia Saint Mary's Water Tower Medical Commons Milwaukee Wisconsin United States 53211
162 Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin United States 53226
163 Clement J. Zablocki VA Medical Center Milwaukee Wisconsin United States 53295
164 Wheaton Franciscan Cancer Care - All Saints Racine Wisconsin United States 53405
165 Door County Cancer Center Sturgeon Bay Wisconsin United States 54235-1495
166 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
167 BCCA-Cancer Centre for the Southern Interior Kelowna British Columbia Canada V1Y 5L3
168 London Regional Cancer Program London Ontario Canada N6A 4L6
169 Ottawa Health Research Institute-General Division Ottawa Ontario Canada K1H 1C4
170 CHUM - Hopital Notre-Dame Montreal Quebec Canada H2L 4M1
171 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
172 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: M. Dror Michaelson, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01546987
Other Study ID Numbers:
  • RTOG 1115
  • CDR0000727326
  • NCI-2012-00700
First Posted:
Mar 7, 2012
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022

Study Results

No Results Posted as of Aug 12, 2022