Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00002602

Recruitment Status : Completed

First Posted : May 26, 2004

Last Update Posted : March 30, 2015

Sponsor:

Collaborators:

National Cancer Institute (NCI)

NRG Oncology

Information provided by (Responsible Party):

Radiation Therapy Oncology Group

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Prostate Cancer	Radiation: 3D-CRT	Phase 1 Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1084 participants
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
Study Start Date :	May 1994
Actual Primary Completion Date :	March 2004
Actual Study Completion Date :	November 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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. ]

Eligibility Criteria

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 of Results:

Michalski J, Winter K, Roach M, Markoe A, Sandler HM, Ryu J, Parliament M, Purdy JA, Valicenti RK, Cox JD. Clinical outcome of patients treated with 3D conformal radiation therapy (3D-CRT) for prostate cancer on RTOG 9406. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):e363-70. doi: 10.1016/j.ijrobp.2011.12.070.

Tucker SL, Dong L, Michalski JM, Bosch WR, Winter K, Cox JD, Purdy JA, Mohan R. Do intermediate radiation doses contribute to late rectal toxicity? An analysis of data from radiation therapy oncology group protocol 94-06. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):390-5. doi: 10.1016/j.ijrobp.2011.11.073. Epub 2012 Feb 17.

Tucker SL, Michalski JM, Bosch WR, Mohan R, Dong L, Winter K, Purdy JA, Cox JD. Use of fractional dose-volume histograms to model risk of acute rectal toxicity among patients treated on RTOG 94-06. Radiother Oncol. 2012 Jul;104(1):109-13. doi: 10.1016/j.radonc.2012.04.023. Epub 2012 Jun 5.

Tucker SL, Thames HD, Michalski JM, Bosch WR, Mohan R, Winter K, Cox JD, Purdy JA, Dong L. Estimation of α/β for late rectal toxicity based on RTOG 94-06. Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):600-5. doi: 10.1016/j.ijrobp.2010.11.080. Epub 2011 Mar 4.

Valicenti RK, Bae K, Michalski J, Sandler H, Shipley W, Lin A, Cox J. Does hormone therapy reduce disease recurrence in prostate cancer patients receiving dose-escalated radiation therapy? An analysis of Radiation Therapy Oncology Group 94-06. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1323-9. doi: 10.1016/j.ijrobp.2010.01.009.

Michalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062.

Tucker SL, Dong L, Bosch WR, Michalski J, Winter K, Mohan R, Purdy JA, Kuban D, Lee AK, Cheung MR, Thames HD, Cox JD. Late rectal toxicity on RTOG 94-06: analysis using a mixture Lyman model. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1253-60. doi: 10.1016/j.ijrobp.2010.01.069. Epub 2010 Jul 2.

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 K, Purdy JA, Parliament M, Wong H, Perez CA, Roach M, Bosch W, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer on RTOG 9406 dose Level V. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):706-13.

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 JM, Winter K, Purdy JA, Perez CA, Ryu JK, Parliament MB, Valicenti RK, Roach M 3rd, Sandler HM, Markoe AM, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):735-42.

Roach M, Winter K, Michalski JM, Cox JD, Purdy JA, Bosch W, Lin X, Shipley WS. Penile bulb dose and impotence after three-dimensional conformal radiotherapy for prostate cancer on RTOG 9406: findings from a prospective, multi-institutional, phase I/II dose-escalation study. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1351-6.

Michalski JM, Winter K, Purdy JA, Wilder RB, Perez CA, Roach M, Parliament MB, Pollack A, Markoe AM, Harms W, Sandler HM, Cox JD. Preliminary evaluation of low-grade toxicity with conformal radiation therapy for prostate cancer on RTOG 9406 dose levels I and II. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):192-8.

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.

Valicenti RK, Winter K, Cox JD, Sandler HM, Bosch W, Vijayakumar S, Michalski J, Purdy J. RTOG 94-06: is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity? Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):614-20.

Michalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402.

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.

Other Publications:

Du KL, Bae K, Movsas B, Yan Y, Bryan C, Bruner DW. Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials. Support Care Cancer. 2012 Jun;20(6):1317-25. doi: 10.1007/s00520-011-1219-4. Epub 2011 Jul 1.

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
First Posted:	May 26, 2004 Key Record Dates
Last Update Posted:	March 30, 2015
Last Verified:	March 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

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