Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer
NCT ID: NCT01546987
Last Updated: 2025-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
239 participants
INTERVENTIONAL
2012-05-31
2025-09-04
Brief Summary
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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.
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Detailed Description
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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.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ADT + RT
Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT.
GnRH agonist
LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable).
Anti-androgen
Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).
Radiation therapy
Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy.
TAK-700 + ADT + RT
TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years.
GnRH agonist
LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable).
Anti-androgen
Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).
TAK-700
300 mg twice daily (BID) (600 mg per day) orally, continuously for 2 years starting with ADT.
Radiation therapy
Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy.
Interventions
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GnRH agonist
LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable).
Anti-androgen
Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).
TAK-700
300 mg twice daily (BID) (600 mg per day) orally, continuously for 2 years starting with ADT.
Radiation therapy
Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. History/physical examination within 60 days prior to registration.
3. Clinically negative lymph nodes as established by imaging \[abdominal and/or pelvic computerized tomography (CT) or abdominal and/or pelvic magnetic resonance imaging (MRI)\], 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.
4. No distant metastases (M0) on bone scan within 90 days prior to registration (18F-Na bone scan is an acceptable substitute).
•Equivocal bone scan findings are allowed if plain films are negative for metastasis.
5. Baseline serum prostate-specific antigen (PSA) value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) or anti-androgen therapy, within 180 days of randomization.
6. 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. Please note: If the patient has started ADT he will not be eligible to participate in the quality of life component of this study.
7. Prior testosterone administration is allowed if last administered at least 90 days prior to registration.
8. Zubrod Performance Status 0-1 within 21 days prior to registration
9. Age ≥ 18
10. Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
11. Serum creatinine \< 2.0 mg/dl and creatinine clearance (can be calculated) \> 40 mL/minute within 21 days prior to registration
12. Bilirubin \< 1.5x upper limit of normal (ULN) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5x ULN within 21 days prior to registration
13. Serum testosterone within 21 days prior to registration
14. Chemistry (including sodium, potassium, chloride, bicarbonate (carbon dioxide), blood urea nitrogen (BUN), glucose, calcium, magnesium and phosphorous) and liver panels (including albumin and alkaline phosphatase) obtained within 21 days prior to registration
15. Fasting glucose, fasting insulin, lipid panel \[cholesterol, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL)\], and Hemoglobin A1C within 21 days prior to registration
16. Screening calculated ejection fraction of ≥ to institutional lower limit of normal by multiple gated acquisition (MUGA) scan or by echocardiogram (ECHO).
17. Baseline electrocardiogram (ECG) within 180 days prior to registration
18. Patients, even if surgically sterilized (ie, status post vasectomy), who:
1. 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, or
2. Agree to completely abstain from intercourse.
19. Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion Criteria
2. Definite evidence of metastatic disease.
3. Pathologically positive lymph nodes or nodes \> 2.0 cm on imaging.
4. Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason.
5. Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years.
6. Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed).
7. Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.
•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 radiation therapy \[EBRT\] only).
8. Previous hormonal therapy for \> 50 days.
9. Known hypersensitivity to TAK-700 or related compounds
10. A history of adrenal insufficiency
11. History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \> 2 \[NCI CTCAE, version 4.02\] (U.S. Department of Health and Human Services, National Institutes of Health National Cancer Institute, 2009), thromboembolic events (eg, 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.
12. New York Heart Association Class III or IV heart failure.
13. ECG abnormalities of:
1. Q-wave infarction, unless identified 6 or more months prior to screening
2. QTc interval \> 460 msec
14. Patients who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
15. Prior allergic reaction to the drugs involved in this protocol.
16. Study entry PSA obtained during the following time frames:
1. 10-day period following prostate biopsy;
2. following initiation of hormonal therapy.
17. Cushing's syndrome
18. Severe chronic renal disease (serum creatinine \> 2.0 mg/dl and confirmed by creatinine clearance \< 40 mL/minute)
19. Chronic liver disease (bilirubin \> 1.5x ULN, ALT or AST \> 2.5x ULN)
20. Chronic treatment with glucocorticoids within one year
21. 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)
22. Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.
23. Major surgery within 14 days prior to registration
24. Serious infection within 14 days prior to registration
25. Uncontrolled nausea, vomiting, or diarrhea \[Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3\] despite appropriate medical therapy at the time of registration
26. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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M. Dror Michaelson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Veterans Administration Long Beach Medical Center
Long Beach, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
University of Southern California/Norris Cancer Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Pomona Valley Hospital Medical Center
Pomona, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter General Hospital
Sacramento, California, United States
University of California At San Diego
San Diego, California, United States
UCSF-Mount Zion
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States
Stanford University Hospitals and Clinics
Stanford, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States
Sutter Solano Medical Center
Vallejo, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
William Backus Hospital
Norwich, Connecticut, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Saint Joseph's-Candler Health System
Savannah, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Idaho Urologic Institute PA
Meridian, Idaho, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Hines Veterans Administration Hospital
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Touro Infirmary
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Saint Anne's Hospital
Fall River, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States
North Shore Medical Center Cancer Center
Peabody, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States
Bixby Medical Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
McLaren-Flint
Flint, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Great Lakes Cancer Institute-Lapeer Campus
Lapeer, Michigan, United States
McLaren Cancer Institute-Owosso
Owosso, Michigan, United States
Northern Michigan Regional Hospital
Petoskey, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Siteman Cancer Center - Saint Peters
City of Saint Peters, Missouri, United States
Kansas City Cancer Center - South
Kansas City, Missouri, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Barnes-Jewish West County Hospital
St Louis, Missouri, United States
Saint John's Mercy Medical Center
St Louis, Missouri, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Concord Hospital
Concord, New Hampshire, United States
Exeter Hospital
Exeter, New Hampshire, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Elliot Hospital
Manchester, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Akron General Medical Center
Akron, Ohio, United States
Summa Barberton Hospital
Barberton, Ohio, United States
Geaugra Hospital
Chardon, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, United States
Summa Health Center at Lake Medina
Medina, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States
UHHS-Chagrin Highlands Medical Center
Orange, Ohio, United States
Robinson Radiation Oncology
Ravenna, Ohio, United States
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
UHHS-Westlake Medical Center
Westlake, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States
Rogue Valley Medical Center
Medford, Oregon, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
The Regional Cancer Center
Erie, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Texas Oncology PA - Bedford
Bedford, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The Klabzuba Cancer Center
Fort Worth, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, United States
Texas Cancer Center-Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, United States
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, United States
Sentara Hospitals
Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, United States
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States
Saint Francis Hospital
Federal Way, Washington, United States
Virginia Mason CCOP
Seattle, Washington, United States
Appleton Medical Center
Appleton, Wisconsin, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Mary's Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States
Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin, United States
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Health Research Institute-General Division
Ottawa, Ontario, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CDR0000727326
Identifier Type: -
Identifier Source: secondary_id
NCI-2012-00700
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG 1115
Identifier Type: -
Identifier Source: org_study_id
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