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RTOG 0712 Protocol Information

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A Phase II Randomized Study for Patients with Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery and Concomitant Chemoradiation by Either BID Irradiation plus 5-Fluorouracil and Cisplatin or QD Irradiation plus Gemcitabine Followed by Selective Bladder Preservation and Gemcitabine/Cisplatin Adjuvant Chemotherapy
Principal Investigator: John J. Coen, MD
Primary Objective:

To estimate the rate of distant metastasis at 3 years of two induction chemoradiotherapy regimens including 5-Fluorouracil, cisplatin, and BID irradiation (FCI) or gemcitabine and QD irradiation (GI). Induction chemoradiotherapy will be followed by radical cystectomy if the initial tumor response is incomplete or by consolidation chemoradiotherapy if the tumor has cleared, and both will be followed by adjuvant chemotherapy.

Patient Population:

Operable Patients with muscularis propria invasion carcinoma of the bladder, all histologies - AJCC Stages T2-T4a, NX or N0, M0 - No histologic evidence of tumor invasion into the stroma of the prostate - No tumor-related hydronephrosis

Target Accrual: 64
Current Accrual: 70
Status: Closed to Accrual
Date: 2/28/2014
Participating Sites:
21st Century Oncology - Carolina Radiation Medicine Greenville NC
21st Century Oncology - Lakewood Ranch Oncology Lakewood Ranch FL
21st Century Oncology-Bradenton Bradenton FL
21st Century Oncology-Clarkston, MI Clarkston MI
21st Century Oncology-Farmington Hills Farmington Hills MI
21st Century Oncology-Fort Walton Beach Fort Walton Beach FL
21st Century Oncology-Scottsdale Scottsdale AZ
ACR Clinical Research Center Philadelphia PA
Akron General Medical Center Akron OH
Allegiance Health Jackson MI
Beaumont Hospital-Dearborn Dearborn MI
Beth Israel Deaconess Medical Center Boston MA
Borgess Medical Center Kalamazoo MI
Brigham and Women's Hospital Boston MA
Bronson Methodist Hospital Kalamazoo MI
Christiana Care Health System-Christiana Hospital Newark DE
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
Duke University Medical Center Durham NC
Emerson Hospital/MGH Cancer Center Concord MA
Emory University Hospital Midtown Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Genesys Hurley Cancer Institute Flint MI
Grady Health System Atlanta GA
Hartford Hospital Hartford CT
Holy Cross Hospital Fort Lauderdale FL
Hurley Medical Center Flint MI
Idaho Urologic Institute-Meridian Meridian ID
Image-Guided Therapy QA Center (ITC) St. Louis MO
Intermountain Medical Center Murray UT
Jupiter Medical Center Jupiter FL
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Lake Huron Medical Center Port Huron MI
LDS Hospital Salt Lake City UT
Logan Regional Hospital Logan UT
Massachusetts General Hospital Boston MA
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
Medical University of South Carolina Charleston SC
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Mount Sinai Medical Center Miami Beach FL
Novant Health Presbyterian Medical Center Charlotte NC
Parkview Hospital Randallia Fort Wayne IN
Penrose-Saint Francis Healthcare Colorado Springs CO
Radiation Oncology Associates PC Fort Wayne IN
Saint Agnes Hospital Baltimore MD
Saint Alphonsus Cancer Care Center-Boise Boise ID
Saint John Hospital and Medical Center Grosse Pointe Woods MI
Saint John Macomb-Oakland Hospital Warren MI
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Joseph Mercy Oakland Pontac MI
Saint Mary Mercy Hospital Livonia MI
Saint Mary's of Michigan Saginaw MI
Sandra L Maxwell Cancer Center Cedar City UT
Smilow Cancer Hospital Care Center at Saint Francis Hartford CT
Sparrow Hospital Lansing MI
St Anne's Hospital Fall River MA
St Johns Hospital, Cancer Institute Springfield IL
The Research Institute of the McGill University Health Centr Montreal
University of Michigan Comprehensive Cancer Center Ann Arbor MI
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Virtua Memorial Mount Holly NJ
Virtua Voorhees Voorhees NJ
Updated: 2/23/2015

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