Clinical trial NCT01546987: Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2012-03-07
Enrollment: 239
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Eligibility criteria: Inclusion Criteria:

1. 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:

   * 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:

1. PSA \> 150
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

Primary outcomes:
measure: Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol)
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Secondary outcomes:
measure: Percentage of Patients Alive [Overall Survival] (Primary Endpoint of Original Protocol)
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
measure: Percentage of Participants With Grade 3 or Higher Adverse Events
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
measure: Percentage of Participants With Local Progression
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates reported.
measure: Percentage of Participants With Distant Metastases
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
measure: Percentage of Participants With General Clinical Treatment Failure
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
measure: Percentage of Participants With Death Due to Prostate Cancer
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
measure: Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form at One Year
timeFrame: Baseline, one year
measure: Change in Patient-reported Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Short Form at One Year
timeFrame: Baseline, one year
measure: Serum Testosterone
timeFrame: Baseline,12 months, 24 months
measure: Fasting Total Cholesterol
timeFrame: Baseline, 12 months, 24 months
measure: Serum High-density Lipoprotein (HDL)
timeFrame: Baseline, 12 months, 24 months
measure: Serum High-density Lipoprotein (LDL)
timeFrame: Baseline, 12 months, 24 months
measure: Hemoglobin A1c
timeFrame: Baseline, 12 months, 24 months
measure: Fasting Plasma Glucose
timeFrame: Baseline, 12 months, 24 months
measure: Fasting Plasma Insulin
timeFrame: Baseline, 12 months, 24 months
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline and yearly to five years.
measure: Number of Participants by Highest Grade Adverse Event
timeFrame: From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
measure: Testosterone Recovery at 12 and 24 Months
timeFrame: From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years.
measure: Median Testosterone Recovery Time
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
measure: Number of Patients With Clinical Survivorship Events
timeFrame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Other outcomes:
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facility: University of Alabama at Birmingham
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city: Phoenix
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city: Chicago
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city: Hines
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city: Maywood
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facility: Loyola University Medical Center
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city: Peoria
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state: Illinois
city: Fort Wayne
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facility: Radiation Oncology Associates PC
state: Indiana
city: Fort Wayne
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facility: Parkview Hospital Randallia
state: Indiana
city: Iowa City
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facility: University of Iowa Hospitals and Clinics
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city: Kansas City
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facility: University of Kansas Medical Center
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city: Overland Park
country: United States
facility: Kansas City Cancer Centers-Southwest
state: Kansas
city: Lexington
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facility: University of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: New Orleans
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facility: Touro Infirmary
state: Louisiana
city: New Orleans
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facility: Ochsner Medical Center Jefferson
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Center- Scarborough Campus
state: Maine
city: Baltimore
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facility: Saint Agnes Hospital
state: Maryland
city: Salisbury
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facility: Peninsula Regional Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Saint Anne's Hospital
state: Massachusetts
city: Milford
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
state: Massachusetts
city: Peabody
country: United States
facility: North Shore Medical Center Cancer Center
state: Massachusetts
city: South Weymouth
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center at South Shore
state: Massachusetts
city: Adrian
country: United States
facility: Bixby Medical Center
state: Michigan
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: McLaren-Flint
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Lapeer
country: United States
facility: Great Lakes Cancer Institute-Lapeer Campus
state: Michigan
city: Owosso
country: United States
facility: McLaren Cancer Institute-Owosso
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Regional Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy
state: Michigan
city: Bemidji
country: United States
facility: Sanford Clinic North-Bemidgi
state: Minnesota
city: Duluth
country: United States
facility: Saint Luke's Hospital of Duluth
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Cape Girardeau
country: United States
facility: Southeast Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Center - South
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city: Kansas City
country: United States
facility: Kansas City Cancer Centers - North
state: Missouri
city: Lee's Summit
country: United States
facility: Kansas City Cancer Center-Lee's Summit
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center-South County
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish West County Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Saint John's Mercy Medical Center
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center - Saint Peters
state: Missouri
city: Springfield
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facility: Mercy Hospital Springfield
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city: Great Falls
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facility: Benefis Healthcare- Sletten Cancer Institute
state: Montana
city: Omaha
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facility: Nebraska Methodist Hospital
state: Nebraska
city: Omaha
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facility: The Nebraska Medical Center
state: Nebraska
city: Concord
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facility: Concord Hospital
state: New Hampshire
city: Exeter
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facility: Exeter Hospital
state: New Hampshire
city: Lebanon
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facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Elliot Hospital
state: New Hampshire
city: Camden
country: United States
facility: Cooper Hospital University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Voorhees
country: United States
facility: MD Anderson Cancer Center at Cooper-Voorhees
state: New Jersey
city: Bismarck
country: United States
facility: Sanford Bismarck Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Medical Center-Fargo
state: North Dakota
city: Akron
country: United States
facility: Summa Akron City Hospital/Cooper Cancer Center
state: Ohio
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Barberton
country: United States
facility: Summa Barberton Hospital
state: Ohio
city: Chardon
country: United States
facility: Geaugra Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Elyria
country: United States
facility: Mercy Cancer Center-Elyria
state: Ohio
city: Medina
country: United States
facility: Summa Health Center at Lake Medina
state: Ohio
city: Mentor
country: United States
facility: Lake University Ireland Cancer Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest General Health Center Ireland Cancer Center
state: Ohio
city: Orange Village
country: United States
facility: UHHS-Chagrin Highlands Medical Center
state: Ohio
city: Ravenna
country: United States
facility: Robinson Radiation Oncology
state: Ohio
city: Sandusky
country: United States
facility: Ireland Cancer Center at Firelands Regional Medical Center
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital
state: Ohio
city: Westlake
country: United States
facility: UHHS-Westlake Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Natalie Warren Bryant Cancer Center at Saint Francis
state: Oklahoma
city: Medford
country: United States
facility: Rogue Valley Medical Center
state: Oregon
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: Erie
country: United States
facility: The Regional Cancer Center
state: Pennsylvania
city: Gettysburg
country: United States
facility: Adams Cancer Center
state: Pennsylvania
city: Hanover
country: United States
facility: Cherry Tree Cancer Center
state: Pennsylvania
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health-York Hospital
state: Pennsylvania
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Bedford
country: United States
facility: Texas Oncology PA - Bedford
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: The Klabzuba Cancer Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Memorial City Medical Center
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: League City
country: United States
facility: UTMB Cancer Center at Victory Lakes
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center-Sherman
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology Cancer Center Sugar Land
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Saint George
country: United States
facility: Dixie Medical Center Regional Cancer Center
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists-Salt Lake City
state: Utah
city: Hampton
country: United States
facility: Sentara Cancer Institute at Sentara CarePlex Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Hospitals
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Virginia Beach General Hospital
state: Virginia
city: Federal Way
country: United States
facility: Saint Francis Hospital
state: Washington
city: Seattle
country: United States
facility: Virginia Mason CCOP
state: Washington
city: Appleton
country: United States
facility: Appleton Medical Center
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Mary's Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran
state: Wisconsin
city: Marinette
country: United States
facility: Bay Area Medical Center
state: Wisconsin
city: Mequon
country: United States
facility: Columbia Saint Mary's Hospital - Ozaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia Saint Mary's Water Tower Medical Commons
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert and the Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center
state: Wisconsin
city: Racine
country: United States
facility: Wheaton Franciscan Cancer Care - All Saints
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Door County Cancer Center
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Kelowna
country: Canada
facility: BCCA-Cancer Centre for the Southern Interior
state: British Columbia
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Health Research Institute-General Division
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Hopital Notre-Dame
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Massachusetts General Hospital
name: M. Dror Michaelson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: