Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer
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 |
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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
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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.
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To compare rates and cumulative incidence of biochemical control (freedom from PSA failure), local/regional progression, and distant metastases.
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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.
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To compare prostate cancer-specific survival and other-cause mortality.
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To compare the change in severity of fatigue as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue short form.
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To compare changes in patient-reported QOL as measured by Expanded Prostate Cancer Index Composite (EPIC).
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To assess quality-adjusted survival using the EQ-5D.
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To compare nadir and average serum testosterone at 12 and 24 months during treatment.
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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.
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To compare changes in fasting lipid levels during 24 months of treatment and during the first three years of follow-up.
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To compare changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up.
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To compare the incidence of adverse events ascertained via CTCAE version 4.
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To compare the rate of recovery of testosterone to > 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up.
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To compare the median time to recovery of testosterone to > 230 ng/dL during the first five years of follow-up.
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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.
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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).
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
- Overall survival [From the date of randomization to the date of death due to any cause.]
Secondary Outcome Measures
- 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.]
- 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.]
- 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.]
- 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.]
- Change in fatigue from baseline to 1 year, as measured by PROMIS [One year from the date of randomization.]
- 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.]
- 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.]
- Nadir and average serum testosterone at 12 and 24 months during treatment [From baseline to 12 months and 24 months of treatment.]
- Lipid profiles at 12 and 24 months [From baseline to 12 months and 24 months.]
- Fasting plasma glucose, fasting plasma insulin, and hemoglobin A1c at 12 and 24 months [From baseline to 12 months and 24 months.]
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
- Rates and cumulative incidence of local/regional progression [From the date of randomization to the date of the documented presence of local/regional recurrence.]
- Rates and cumulative incidence of distant metastases [From the date of randomization to the date of documented distant recurrence.]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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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):
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Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage
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GS ≥ 8, PSA < 20 ng/mL, T stage ≥ T2
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GS ≥ 8, PSA ≥ 20-150 ng/mL, any T stage
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GS ≥ 7, PSA ≥ 20-150 ng/mL, any T stage
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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
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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
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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
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Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 2.0 cm
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No distant metastases (M0) on bone scan within 90 days prior to registration
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Equivocal bone scan findings are allowed if plain films are negative for metastasis
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No definite evidence of metastatic disease
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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)
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Prior TURP is permitted for patients who receive external-beam radiotherapy (EBRT) only
PATIENT CHARACTERISTICS:
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Height, weight, Zubrod performance status 0-1
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Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3
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Platelets ≥ 100,000 cells/mm^3
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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)
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Alanine aminotranserase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
-
No PSA > 150 ng/mL
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Screening calculated ejection fraction ≥ ULN by multiple-gated acquisition (MUGA) scan or by echocardiogram
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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.
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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
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No prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years
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No known hypersensitivity to TAK-700 or related compounds
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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
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Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
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No New York Heart Association Class III or IV heart failure
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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
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No severe chronic renal disease or chronic liver disease
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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)
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No serious infection within 14 days prior to registration
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No uncontrolled nausea, vomiting, or diarrhea (CTCAE grade ≥ 3) despite appropriate medical therapy at the time of registration
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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
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No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
-
No prior systemic chemotherapy for prostate cancer
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Prior chemotherapy for a different cancer is allowed
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No prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields
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No previous hormonal therapy for > 50 days
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No chronic treatment with glucocorticoids within one year
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No major surgery within 14 days prior to registration
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No other investigational agent
-
No other anticancer therapy
-
No concurrent hormonal therapies including estrogens or herbal products
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No concurrent ketoconazole or aminoglutethimide
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No chronic use of systemic corticosteroids, such as oral prednisone
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- RTOG 1115
- CDR0000727326
- NCI-2012-00700