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Phase III Randomized Study of Hypofractionated Versus Conventionally Fractionated Three-Dimensional Conformal or Intensity-Modulated Radiotherapy in Patients With Favorable-Risk Stage II Prostate Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Basic Trial Information
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Protocol IDs
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Phase III

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Treatment

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Active

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18 and over

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NCI

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RTOG-0415 RTOG-0415, NCT00331773

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Special Category:
NCI Web site featured trial, CTSU trial Objectives Primary - Compare the disease-free survival (DFS) of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT).
Secondary - Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
- Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
- Compare the degree, duration, and significant differences in disease-specific health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer Index Composite (EPIC), in patients treated with these regimens.
- Determine whether anxiety and/or depression, as measured by the Hopkins Symptom Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients .
- Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression) in patients treated with these regimens.
- Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS.
Entry Criteria Disease Characteristics:
- Histologically confirmed adenocarcinoma of the prostate within the past 6 months
- Combined Gleason score 2-6
- Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months
- No PSA measurement for ≥ 10 days after prostate biopsy
- No PSA measurement for ≥ 30 days after discontinuation of finasteride (90 days after discontinuation of dutasteride)
- No regional lymph node involvement
- No distant metastases
Prior/Concurrent Therapy:
- See Disease Characteristics
- No prior radical prostatectomy or cryosurgery for prostate cancer
- No prior hormonal therapy, including any of the following:
- Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
- Antiandrogens (e.g., flutamide or bicalutamide)
- Estrogens (e.g., diethylstilbestrol [DES])
- Surgical castration (bilateral orchiectomy)
- No prior pelvic radiotherapy or prostate brachytherapy
- No prior or concurrent cytotoxic chemotherapy for prostate cancer
- At least 30 days since prior finasteride
- At least 90 days since prior dutasteride
- No concurrent neoadjuvant or adjuvant hormonal therapy
- Concurrent warfarin or other blood-thinning agents allowed
Patient Characteristics:
- Zubrod performance status 0-1
- No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- No transmural myocardial infarction within the past 6 months
- No acute bacterial or fungal infection requiring IV antibiotics
- No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- No known AIDS
- No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
- No other severe, active comorbidity
Expected Enrollment 1067A total of 1,067 patients will be accrued to this study. Outcomes Primary Outcome(s)Disease-free survival at 5 years as measured by Kaplan-Meier
Secondary Outcome(s)Time to failure Disease-specific survival Freedom from biochemical recurrence (FFBR) Overall survival Incidence of GU and GI acute and late toxicity Statistical modeling of genomic biomarkers Comparison of disease-specific HRQOL change in EPIC; the Utilization of Sexual Medications/Devices supplements the EPIC Assessment of anxiety and depression change using the HSCL-25 Evaluation and comparison of the cost-utility of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis Collection of paraffin-embedded tissue block, serum, plasma, and buffy coat cells for future translational research analyses
Outline This is a randomized, controlled, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (< 4 ng/mL vs 4-9 ng/mL), and planned radiotherapy modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 8.2 weeks (total of 41 treatments).
- Arm II: Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 5.6 weeks (total of 28 treatments).
Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1, 2, and 5 years after the start of radiotherapy. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations Radiation Therapy Oncology Group  |  |  | | W. Robert Lee, MD, Protocol chair |  | |  | Trial Sites
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| U.S.A. |
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| Alabama |
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Mobile |
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| | | | | Mobile Infirmary Medical Center |
| | | Clinical Trials Office - Mobile Infirmary Medical Center | |
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| Arizona |
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Phoenix |
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| | | | Arizona Oncology Services Foundation |
| | | David Brachman, MD, FACRO | |
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Scottsdale |
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| | | Mayo Clinic Scottsdale |
| | | Clinical Trials Office - All Mayo Clinic Locations | |
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Tucson |
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| | | Arizona Oncology - Tucson |
| | | Vivek Kavadi | |
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| California |
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Auburn |
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| | | | Auburn Radiation Oncology |
| | | Seth Rosenthal | |
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Berkeley |
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| | | Alta Bates Summit Comprehensive Cancer Center |
| | | Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center | |
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Burbank |
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| | | Providence Saint Joseph Medical Center - Burbank |
| | | Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank | |
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Burlingame |
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| | | Peninsula Medical Center |
| | | David Irwin, MD | |
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Cameron Park |
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| | | Radiation Oncology Centers - Cameron Park |
| | | Seth Rosenthal | |
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Carmichael |
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| | | Mercy Cancer Center at Mercy San Juan Medical Center |
| | | Seth Rosenthal | |
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Castro Valley |
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| | | East Bay Radiation Oncology Center |
| | | James Feusner, MD | |
| | | Valley Medical Oncology Consultants - Castro Valley |
| | | James Feusner, MD | |
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Fremont |
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| | | Valley Medical Oncology |
| | | James Feusner, MD | |
| | | Washington Township Hospital |
| | | Byron Wilson, MD | |
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Greenbrae |
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| | | Marin Cancer Institute at Marin General Hospital |
| | | David Irwin, MD | |
| | | Sutter Health - Western Division Cancer Research Group |
| | | David Irwin, MD | |
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Hayward |
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| | | Kaiser Permanente Medical Center - Hayward |
| | | Louis Fehrenbacher, MD | |
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Long Beach |
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| | | Veterans Affairs Medical Center - Long Beach |
| | | Samar Azawi, MD | |
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Los Angeles |
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| | | Kaiser Permanente Medical Center - Los Angeles |
| | | Michael Girvigian | | Ph: | 323-667-4011 | | 800-954-8000 |
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Oakland |
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| | | Alta Bates Summit Medical Center - Summit Campus |
| | | Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus | |
| | | Bay Area Breast Surgeons, Incorporated |
| | | James Feusner, MD | |
| | | CCOP - Bay Area Tumor Institute |
| | | James Feusner, MD | |
| | | Kaiser Permanente Medical Center - Oakland |
| | | Louis Fehrenbacher, MD | |
| | | Larry G Strieff MD Medical Corporation |
| | | James Feusner, MD | |
| | | Tom K Lee, Incorporated |
| | | James Feusner, MD | |
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Pleasanton |
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| | | Valley Medical Oncology Consultants - Pleasanton |
| | | James Feusner, MD | |
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Redwood City |
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| | | Kaiser Permanente Medical Center - Redwood City |
| | | Louis Fehrenbacher, MD | |
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Richmond |
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| | | Kaiser Permanente Medical Center - Richmond |
| | | Louis Fehrenbacher, MD | |
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Roseville |
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| | | Kaiser Permanente Medical Center - Roseville |
| | | Louis Fehrenbacher, MD | |
| | | Radiation Oncology Center - Roseville |
| | | Seth Rosenthal | |
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Sacramento |
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| | | Kaiser Permanente Medical Center - Sacramento |
| | | Louis Fehrenbacher, MD | |
| | | Mercy General Hospital |
| | | Seth Rosenthal | |
| | | Radiological Associates of Sacramento Medical Group, Incorporated |
| | | Seth Rosenthal | |
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San Francisco |
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| | | California Pacific Medical Center - California Campus |
| | | David Irwin, MD | |
| | | Kaiser Permanente Medical Center - San Francisco Geary Campus |
| | | Louis Fehrenbacher, MD | |
| | | UCSF Helen Diller Family Comprehensive Cancer Center |
| | | Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center | |
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San Jose |
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| | | Kaiser Permanente Medical Center - Santa Teresa |
| | | Louis Fehrenbacher, MD | |
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San Pablo |
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| | | Doctors Medical Center - San Pablo Campus |
| | | James Feusner, MD | |
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San Rafael |
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| | | Kaiser Foundation Hospital - San Rafael |
| | | Louis Fehrenbacher, MD | |
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Santa Clara |
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| | | Louis Fehrenbacher, MD | |
| | | Kaiser Permanente Medical Center - Santa Clara Kiely Campus |
| | | Louis Fehrenbacher, MD | |
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Santa Rosa |
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| | | Kaiser Permanente Medical Center - Santa Rosa |
| | | Louis Fehrenbacher, MD | |
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South San Francisco |
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| | | Kaiser Permanente Medical Center - South San Francisco |
| | | Louis Fehrenbacher, MD | |
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Torrance |
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| | | Torrance Memorial Medical Center |
| | | Thyra Endicott, MD | |
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Travis AFB |
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| | | General Robert Huyser Cancer Center at David Grant Medical Center |
| | | Roland Engel, MD | |
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Vacaville |
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| | | Solano Radiation Oncology Center |
| | | Seth Rosenthal | |
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Vallejo |
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| | | Sutter Solano Medical Center |
| | | David Irwin, MD | |
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Walnut Creek |
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| | | Kaiser Permanente Medical Center - Walnut Creek |
| | | Louis Fehrenbacher, MD | |
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| Colorado |
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Aurora |
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| | | | Aurora Presbyterian Hospital |
| | | Eduardo Pajon, MD | |
| | | Rocky Mountain Cancer Centers - Aurora |
| | | Vivek Kavadi | |
| | | University of Colorado Cancer Center at UC Health Sciences Center |
| | | Clinical Trials Office - University of Colorado Cancer Center | |
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Colorado Springs |
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| | | Penrose Cancer Center at Penrose Hospital |
| | | Clinical Trials Office - Penrose Cancer Center | |
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Denver |
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| | | Porter Adventist Hospital |
| | | Eduardo Pajon, MD | |
| | | Presbyterian - St. Luke's Medical Center |
| | | Clinical Trials Office - Presbyterian - St. Luke's Medical Center | |
| | | St. Joseph Hospital |
| | | Eduardo Pajon, MD | |
| | | Veterans Affairs Medical Center - Denver |
| | | Rachel Rabinovitch, MD | |
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Englewood |
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| | | Swedish Medical Center |
| | | Eduardo Pajon, MD | |
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Fort Collins |
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| | | Poudre Valley Radiation Oncology |
| | | C. Kelley Simpson, MD | |
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Grand Junction |
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| | | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center |
| | | Eduardo Pajon, MD | |
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Greeley |
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| | | North Colorado Medical Center |
| | | Eduardo Pajon, MD | |
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Lone Tree |
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| | | Sky Ridge Medical Center |
| | | Eduardo Pajon, MD | |
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Longmont |
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| | | Hope Cancer Care Center at Longmont United Hospital |
| | | Eduardo Pajon, MD | |
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Loveland |
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| | | McKee Medical Center |
| | | Eduardo Pajon, MD | |
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Pueblo |
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| | | St. Mary - Corwin Regional Medical Center |
| | | Eduardo Pajon, MD | |
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Thornton |
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| | | North Suburban Medical Center |
| | | Eduardo Pajon, MD | |
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Wheat Ridge |
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| | | Exempla Lutheran Medical Center |
| | | Clinical Trials Office - Exempla Lutheran Medical Center | |
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| Delaware |
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Newark |
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| | | | CCOP - Christiana Care Health Services |
| | | Clinical Trial Office - CCOP - Christiana Care Health Services | |
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| Florida |
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Gainesville |
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| | | | University of Florida Shands Cancer Center |
| | | Clinical Trials Office - University of Florida Shands Cancer Center | |
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Jacksonville |
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| | | Mayo Clinic - Jacksonville |
| | | Clinical Trials Office - All Mayo Clinic Locations | |
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Miami |
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| | | Baptist-South Miami Regional Cancer Program |
| | | Andre Abitbol, MD | |
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Panama City |
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| | | Bay Medical |
| | | Hasan Murshed | |
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| Georgia |
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Altanta |
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| | | | Winship Cancer Institute of Emory University |
| | | Ashesh Jani | |
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Atlanta |
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| | | Emory Crawford Long Hospital |
| | | Ashesh Jani | |
| | | Georgia Cancer Center for Excellence at Grady Memorial Hospital |
| | | Ashesh Jani | |
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Decatur |
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| | | Veterans Affairs Medical Center - Atlanta (Decatur) |
| | | Scott Edelman | |
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| Illinois |
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Alton |
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| | | | Saint Anthony's Hospital at Saint Anthony's Health Center |
| | | Bethany Sleckman, MD | |
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Bloomington |
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| | | St. Joseph Medical Center |
| | | John Kugler, MD | |
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Chicago |
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| | | University of Chicago Cancer Research Center |
| | | Clinical Trials Office - University of Chicago Cancer Research Center | |
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Decatur |
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| | | Decatur Memorial Hospital Cancer Care Institute |
| | | Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute | |
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Galesburg |
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| | | InterCommunity Cancer Center of Western Illinois |
| | | John Kugler, MD | |
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Normal |
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| | | BroMenn Regional Medical Center |
| | | John Kugler, MD | |
| | | Community Cancer Center |
| | | John Kugler, MD | |
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Olympia Fields |
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| | | Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields |
| | | Clinical Trials Office - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | |
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Pekin |
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| | | Cancer Treatment Center at Pekin Hospital |
| | | John Kugler, MD | |
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Peoria |
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| | | CCOP - Illinois Oncology Research Association |
| | | John Kugler, MD | |
| | | Methodist Medical Center of Illinois |
| | | Clinical Trials Office - Methodist Medical Center of Illinois | |
| | | Oncology Hematology Associates of Central Illinois, PC - Peoria |
| | | John Kugler, MD | |
| | | John Kugler, MD | |
| | | OSF St. Francis Medical Center |
| | | John Kugler, MD | |
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Spring Valley |
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| | | Valley Cancer Center |
| | | John Kugler, MD | |
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| Indiana |
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Indianapolis |
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| | | | Central Indiana Cancer Centers - East |
| | | Vivek Kavadi | | |