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Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
This study has been completed.
Sponsor:
Radiation Therapy Oncology Group
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002602
First received: November 1, 1999
Last updated: March 26, 2015
Last verified: March 2015
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Prostate Cancer | Radiation: 3D-CRT | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
Further study details as provided by Radiation Therapy Oncology Group:
Primary Outcome Measures:
- To establish the maximum tolerated dose (MTD) of radiation that can be delivered to the prostate gland and immediate surrounding tissues in patients with carcinoma of the prostate using three dimensional conformal radiation therapy (3D-CRT). [ Time Frame: From registration to approximately 18 months from the start of treatment ]
Secondary Outcome Measures:
- To quantify the normal tissue toxicity rate (normal tissue complication probability (NTCP)) for rectum and bladder using 3D-CRT [ Time Frame: From registration to approximately 18 months from the start of treatment ]
- To evaluate local control by clinical, pathologic, and PSA (stable in normal range) determinations [ Time Frame: From registration to the date of progression or last follow-up. Analysis will occur after the primary endpoint analysis. ]
- Distant metastasis and survival [ Time Frame: From registration to the date of death or last follow-up. Analysis will occur after the primary endpoint analysis. ]
| Enrollment: | 1084 |
| Study Start Date: | May 1994 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Clinical stages T1b-c or T2a-b with PSA + ([Gleason -6] x 10) is ≤ 15. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.
|
Radiation: 3D-CRT
3 dimensional conformal radiation therapy
Other Name: 3 dimensional conformal radiation therapy
|
|
Experimental: Group 2
Clinical stages T1b-c or T2a-b with PSA + ([Gleason -6]x10)>15. Any clinical T2c with PSA < 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.
|
Radiation: 3D-CRT
3 dimensional conformal radiation therapy
Other Name: 3 dimensional conformal radiation therapy
|
|
Experimental: Group 3
Clinical stage T3 with PSA < 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.
|
Radiation: 3D-CRT
3 dimensional conformal radiation therapy
Other Name: 3 dimensional conformal radiation therapy
|
Detailed Description:
OBJECTIVES: I. Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy to the prostate gland and immediately surrounding tissues in patients with stage II or III adenocarcinoma of the prostate. II. Determine the normal tissue toxicity rate of this regimen in the rectums and bladders of these patients. III. Determine local control by clinical and pathologic examination and by PSA determinations in patients treated with this regimen. IV. Determine the distant failure and overall survival of patients treated with this regimen.
OUTLINE: This is a dose escalation study. Patients are stratified according to 1 of the following 3 prognostic groups: Group 1: T1b-c or T2a-b with combined PSA/Gleason (CPG) score 15 and under Group 2: T1b-c or T2a-b with CPG score more than 15, or any T2c with PSA less than 70 ng/mL Group 3: T3 with prostate specific antigen (PSA) less than 70 ng/mL Patients receive 3-dimensional (3-D) conformal radiotherapy 5 days a week for 7.6, 8.2, or 8.8 weeks. Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 20% of patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 549-801 patients (120-204 patients for the first dose level, 237-321 patients for the second dose level, and 192-276 patients for the third dose level) will be accrued for this study within 4.75 to 5.25 years.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS: Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven regional nodal involvement No distant metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No other malignancy within the past 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior pelvic irradiation Surgery: No prior prostatectomy or cryosurgery for prostate cancer
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002602
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002602
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Locations
| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| Comprehensive Cancer Institute of Huntsville | |
| Huntsville, Alabama, United States, 35801 | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36640-0460 | |
| MBCCOP - University of South Alabama | |
| Mobile, Alabama, United States, 36688 | |
| Alabama Oncology, LLC | |
| Montgomery, Alabama, United States, 36106-2801 | |
| Radiation Oncology Associates of West Alabama | |
| Tuscaloosa, Alabama, United States, 35401 | |
| United States, Alaska | |
| Providence Cancer Therapy Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Mount Diablo Medical Center | |
| Concord, California, United States, 94524-4110 | |
| California Cancer Center | |
| Fresno, California, United States, 93720 | |
| Saint Agnes Cancer Center | |
| Fresno, California, United States, 93720 | |
| Glendale Memorial Hospital and Health Center | |
| Glendale, California, United States, 91204 | |
| Sutter Health Western Division Cancer Research Group | |
| Greenbrae, California, United States, 94904 | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Veterans Affairs Medical Center - Long Beach | |
| Long Beach, California, United States, 90822 | |
| Kaiser Permanente Medical Center - Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033-0800 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Beckman Research Institute, City of Hope | |
| Los Angeles, California, United States, 91010 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| Cancer Care Center | |
| Pomona, California, United States, 91767 | |
| Radiation Oncology Center - Sacramento | |
| Sacramento, California, United States, 95816 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94115-0128 | |
| O'Connor Hospital | |
| San Jose, California, United States, 95128 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Bridgeport Hospital | |
| Bridgeport, Connecticut, United States, 06610 | |
| Whittingham Cancer Center | |
| Norwalk, Connecticut, United States, 06856 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| Halifax Medical Center | |
| Daytona Beach, Florida, United States, 32114 | |
| Radiation Therapy Associates - Fort Myers | |
| Fort Myers, Florida, United States, 33901 | |
| University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-0296 | |
| Health First Holmes Regional Medical Center | |
| Melbourne, Florida, United States, 32901 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| Baptist Hospital of Miami | |
| Miami, Florida, United States, 33176-2197 | |
| Florida Radiation Oncology Group | |
| Orange Park, Florida, United States, 32073 | |
| MD Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| Gulf Coast Cancer Treatment Center | |
| Panama City, Florida, United States, 32405-4587 | |
| West Florida Cancer Institute - Pensacola | |
| Pensacola, Florida, United States, 32514 | |
| Bayfront Medical Center | |
| Saint Petersburg, Florida, United States, 33701 | |
| Sarasota Radiation and Medical Oncology Center | |
| Sarasota, Florida, United States, 34233 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Medical Center/John B. Amos Community Cancer Center | |
| Columbus, Georgia, United States, 31902 | |
| InterCommunity Cancer Center at Rome | |
| Rome, Georgia, United States, 30161 | |
| United States, Illinois | |
| Northwest Community Hospital | |
| Arlington Heights, Illinois, United States, 60005 | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| United States, Indiana | |
| St. John's Medical Center | |
| Anderson, Indiana, United States, 46016 | |
| Clarion Health Partners Inc. | |
| Indianapolis, Indiana, United States, 46206-1367 | |
| Community Hospitals of Indianapolis - Regional Cancer Center | |
| Indianapolis, Indiana, United States, 46219 | |
| Ball Memorial Hospital | |
| Muncie, Indiana, United States, 47303-3499 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| St. Joseph's Radiation Oncology Center | |
| South Bend, Indiana, United States, 46617 | |
| United States, Iowa | |
| Wendt Regional Cancer Center of Finley Hospital | |
| Dubuque, Iowa, United States, 52001 | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40511-1093 | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| Louisville Radiation Oncology | |
| Louisville, Kentucky, United States, 40215 | |
| Merle M. Mahr Cancer Center | |
| Madisonville, Kentucky, United States, 42431 | |
| Western Baptist Hospital | |
| Paducah, Kentucky, United States, 42001 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Romagosa Radiation Oncology Center | |
| Lafayette, Louisiana, United States, 70501 | |
| MBCCOP - LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Anne Arundel Oncology Center | |
| Annapolis, Maryland, United States, 21401 | |
| Greater Baltimore Medical Center and Cancer Center | |
| Baltimore, Maryland, United States, 21204 | |
| Harbor Hospital Center | |
| Baltimore, Maryland, United States, 21225 | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231 | |
| Radiation Oncology Affiliates of Maryland, P.A. | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Massachusetts | |
| Cape Cod Hospital | |
| Hyannis, Massachusetts, United States, 02601 | |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| McLaren Regional Cancer Center | |
| Flint, Michigan, United States, 48432 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Marquette General Hospital | |
| Marquette, Michigan, United States, 49855 | |
| MidMichigan Regional Medical Center | |
| Midland, Michigan, United States, 48670 | |
| St. Mary's Medical Center | |
| Saginaw, Michigan, United States, 48601 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| Mallinckrodt Institute of Radiology | |
| Saint Louis, Missouri, United States, 63110 | |
| Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Methodist Cancer Center - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| Elliot Regional Cancer Center | |
| Manchester, New Hampshire, United States, 03103 | |
| United States, New Jersey | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| John F. Kennedy Medical Center | |
| Edison, New Jersey, United States, 08818 | |
| Trinitas Hospital - Jersey Street Campus | |
| Elizabeth, New Jersey, United States, 07201 | |
| South Jersey Hospital - Millville | |
| Millville, New Jersey, United States, 08332 | |
| Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | |
| Mount Holly, New Jersey, United States, 08060 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Community Medical Center | |
| Toms River, New Jersey, United States, 08755 | |
| St. Francis Medical Center | |
| Trenton, New Jersey, United States, 08629 | |
| United States, New Mexico | |
| Saint Joseph Medical Center | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Cancer Center of Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| State University of New York Health Science Center at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| New York Methodist Hospital | |
| Brooklyn, New York, United States, 11215-3609 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Finger Lakes Radiation Oncology, P.C. | |
| Clifton Springs, New York, United States, 14432 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| Kaplan Cancer Center | |
| New York, New York, United States, 10016 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Champlain Valley Physicians Hospital Medical Center | |
| Plattsburgh, New York, United States, 12901 | |
| Vassar Brothers Hospital | |
| Poughkeepsie, New York, United States, 12601 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Northeast Medical Center | |
| Concord, North Carolina, United States, 28025 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Catawba Memorial Hospital | |
| Hickory, North Carolina, United States, 28601 | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, North Dakota | |
| Meritcare Roger Maris Cancer Center | |
| Fargo, North Dakota, United States, 58122 | |
| UNIMED Medical Center | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44302 | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44309 | |
| Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, Oklahoma | |
| St. John Medical Center | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
| Penn State Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Mercy Catholic Medical Center, Mercy Fitzgerald Divison | |
| Darby, Pennsylvania, United States, 19023 | |
| Delaware County Memorial Hospital | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Penn State Geisinger Cancer Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Veterans Affairs Medical Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Mercy Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| Mercy Hospital Cancer Center - Scranton | |
| Scranton, Pennsylvania, United States, 18501 | |
| Wilkes Barre General Hospital | |
| Wilkes-Barre, Pennsylvania, United States, 18764 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| York Hospital | |
| York, Pennsylvania, United States, 17315 | |
| United States, Rhode Island | |
| Roger Williams Medical Center/BUSM | |
| Providence, Rhode Island, United States, 02908-4735 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Jackson-Madison County General Hospital | |
| Jackson, Tennessee, United States, 38301 | |
| Baptist Regional Cancer Center - Knoxville | |
| Knoxville, Tennessee, United States, 37901 | |
| CCOP - Baptist Cancer Institute | |
| Memphis, Tennessee, United States, 38117 | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38163 | |
| Vanderbilt Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| Julie and Ben Rogers Cancer Institute | |
| Beaumont, Texas, United States, 77701 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-1329 | |
| Wilford Hall - 59th Medical Wing | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| Bayshore Medical Center | |
| Pasadena, Texas, United States, 77504 | |
| East Texas Medical Center - Cancer Institute | |
| Tyler, Texas, United States, 75701 | |
| United States, Utah | |
| Dixie Regional Medical Center | |
| Saint George, Utah, United States, 84770 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| United States, Vermont | |
| CCOP - Southwestern Vermont Regional Cancer Center | |
| Bennington, Vermont, United States, 05201 | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| Green Mountain Oncology Group | |
| Rutland, Vermont, United States, 05701 | |
| United States, Virginia | |
| Martha Jefferson Hospital | |
| Charlottesville, Virginia, United States, 22901 | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Baptist Hospital | |
| Lynchburg, Virginia, United States, 24503 | |
| Naval Medical Center, Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| United States, Washington | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98111 | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Yakima Valley Memorial Hospital | |
| Yakima, Washington, United States, 98902 | |
| United States, West Virginia | |
| Schiffler Cancer Center | |
| Wheeling, West Virginia, United States, 26003 | |
| United States, Wisconsin | |
| St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Gundersen Lutheran Medical Foundation | |
| La Crosse, Wisconsin, United States, 54601 | |
| Southern Wisconsin Radiotherapy Center | |
| Madison, Wisconsin, United States, 53713 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Community Memorial Hospital | |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| St. Joseph's Hospital | |
| Milwaukee, Wisconsin, United States, 53210 | |
| Columbia Hospital | |
| Milwaukee, Wisconsin, United States, 53211 | |
| St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Southeastern Wisconsin Regional Cancer Center | |
| Racine, Wisconsin, United States, 53405 | |
| Waukesha Memorial Hospital | |
| Waukesha, Wisconsin, United States, 53188 | |
| Canada, Alberta | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, New Brunswick | |
| Doctor Leon Richard Oncology Centre | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Regional Cancer Centre - Civic Campus | |
| Ottawa, Ontario, Canada, K1Y 4K7 | |
| Northeastern Ontario Regional Cancer Centre, Sudbury | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Northwestern Ontario Regional Cancer Centre, Thunder Bay | |
| Thunder Bay, Ontario, Canada, P7A 7T1 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| McGill University Department of Oncology | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
| Study Chair: | James D. Cox, MD | M.D. Anderson Cancer Center |
More Information
Publications:
Cheung MR, Tucker SL, Dong L, et al.: Dose-volume analyses of grade ≥ 2 late rectal toxicity among patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-16, S9, 2007.
Tucker SL, Dong L, Bosch WR, et al.: Fit of a generalized Lyman normal-tissue complication probability (NTCP) model to grade ≥ 2 late rectal toxicity data from patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-15, S8-9, 2007.
Valicenti RK, Bae K, Michalski J, et al.: Does adjuvant hormonal therapy improve freedom from biochemical relapse in prostate cancer patients receiving dose- escalated radiation therapy? An analysis of RTOG 94-06. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-297, 2007.
Michalski JM, Winter KA, Roach M: Clinical outcome of patients treated with 3D conformal radiation therapy 3D-CRT for prostate cancer on RTOG 9406. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-84, 2005.
Michalski JM, Winter KA, Roach M, et al.: Clinical outcome of patients treated with 3D conformal radiation therapy 3D-CRT for prostate cancer on RTOG 9406. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-66, S169, 2004.
Michalski J, Winter K, Purdy JA, et al.: Toxicity following 3D radiation therapy for prostate cancer on RTOG 9406 dose level V. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S151, 2003.
Michalski JM, Winter K, Purdy JA, et al.: Update of toxicity following 3D radiation therapy for prostate cancer on RTOG 9406. Int J Radiat Oncol Biol Phys 48(3 suppl): A-233, 228, 2000.
Roach M, Winter K, Michalski J, et al.: Mean dose of radiation to the bulb of penis correlates with risk of impotence at 24 months: preliminary analysis of Radiation Therapy Oncology Group (RTOG) phase I/II dose escalation trial 94-06. Int J Radiat Oncol Biol Phys 48(3 suppl): A-2104, 316, 2000.
Roach M, Moughan J, Movsas B, et al.: Socio-demographic predictors of biochemical failure and survival among high risk patients treated on Radiation Therapy Oncology Group (RTOG) prostate cancer trials: a meta-analysis. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1127, S204, 2006.
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002602 History of Changes |
| Other Study ID Numbers: |
RTOG-3D/OG-9406 CDR0000063854 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 26, 2015 |
Keywords provided by Radiation Therapy Oncology Group:
|
adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on August 17, 2017