Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE
2 other identifiers
interventional
1,084
2 countries
228
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started May 1994
Longer than P75 for phase_1 prostate-cancer
228 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedFirst Posted
Study publicly available on registry
May 26, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 10, 2020
March 1, 2015
9.8 years
November 1, 1999
January 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
From registration to approximately 18 months from the start of treatment
Secondary Outcomes (3)
To quantify the normal tissue toxicity rate (normal tissue complication probability (NTCP)) for rectum and bladder using 3D-CRT
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
From registration to the date of progression or last follow-up. Analysis will occur after the primary endpoint analysis.
Distant metastasis and survival
From registration to the date of death or last follow-up. Analysis will occur after the primary endpoint analysis.
Study Arms (3)
Group 1
EXPERIMENTALClinical 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.
Group 2
EXPERIMENTALClinical 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.
Group 3
EXPERIMENTALClinical 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.
Interventions
3 dimensional conformal radiation therapy
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (228)
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460, United States
MBCCOP - University of South Alabama
Mobile, Alabama, 36688, United States
Alabama Oncology, LLC
Montgomery, Alabama, 36106-2801, United States
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, 35401, United States
Providence Cancer Therapy Center
Anchorage, Alaska, 99508, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Mount Diablo Medical Center
Concord, California, 94524-4110, United States
California Cancer Center
Fresno, California, 93720, United States
Saint Agnes Cancer Center
Fresno, California, 93720, United States
Glendale Memorial Hospital and Health Center
Glendale, California, 91204, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, 90027, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
Cancer Care Center
Pomona, California, 91767, United States
Radiation Oncology Center - Sacramento
Sacramento, California, 95816, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128, United States
O'Connor Hospital
San Jose, California, 95128, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403, United States
Stanford University
Stanford, California, 94305, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center
Denver, Colorado, 80262, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Whittingham Cancer Center
Norwalk, Connecticut, 06856, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
Halifax Medical Center
Daytona Beach, Florida, 32114, United States
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, 33901, United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33176-2197, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Radiation Oncology Group
Orange Park, Florida, 32073, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587, United States
West Florida Cancer Institute - Pensacola
Pensacola, Florida, 32514, United States
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, 34233, United States
Bayfront Medical Center
St. Petersburg, Florida, 33701, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701, United States
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, 31902, United States
InterCommunity Cancer Center at Rome
Rome, Georgia, 30161, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
St. John's Medical Center
Anderson, Indiana, 46016, United States
Clarion Health Partners Inc.
Indianapolis, Indiana, 46206-1367, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, 46219, United States
Ball Memorial Hospital
Muncie, Indiana, 47303-3499, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
St. Joseph's Radiation Oncology Center
South Bend, Indiana, 46617, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Louisville Radiation Oncology
Louisville, Kentucky, 40215, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, 42431, United States
Western Baptist Hospital
Paducah, Kentucky, 42001, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Romagosa Radiation Oncology Center
Lafayette, Louisiana, 70501, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04102, United States
Anne Arundel Oncology Center
Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204, United States
Harbor Hospital Center
Baltimore, Maryland, 21225, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231, United States
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, 21237, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Regional Cancer Center
Flint, Michigan, 48432, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
Marquette General Hospital
Marquette, Michigan, 49855, United States
MidMichigan Regional Medical Center
Midland, Michigan, 48670, United States
St. Mary's Medical Center
Saginaw, Michigan, 48601, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095, United States
John F. Kennedy Medical Center
Edison, New Jersey, 08818, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201, United States
South Jersey Hospital - Millville
Millville, New Jersey, 08332, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
St. Francis Medical Center
Trenton, New Jersey, 08629, United States
Saint Joseph Medical Center
Albuquerque, New Mexico, 87102, United States
Cancer Center of Albany Medical Center
Albany, New York, 12208, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215-3609, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Finger Lakes Radiation Oncology, P.C.
Clifton Springs, New York, 14432, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Kaplan Cancer Center
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901, United States
Vassar Brothers Hospital
Poughkeepsie, New York, 12601, United States
University of Rochester Cancer Center
Rochester, New York, 14642, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
New York Medical College
Valhalla, New York, 10595, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Northeast Medical Center
Concord, North Carolina, 28025, United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354, United States
Catawba Memorial Hospital
Hickory, North Carolina, 28601, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082, United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
UNIMED Medical Center
Minot, North Dakota, 58701, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
Akron City Hospital
Akron, Ohio, 44309, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210, United States
CCOP - Dayton
Kettering, Ohio, 45429, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456, United States
St. John Medical Center
Tulsa, Oklahoma, 74104, United States
CCOP - Columbia River Program
Portland, Oregon, 97213, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Penn State Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, 19023, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
York Hospital
York, Pennsylvania, 17315, United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901, United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, 38117, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38163, United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, 77701, United States
University of Texas Medical Branch
Galveston, Texas, 77555-1329, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894, United States
Bayshore Medical Center
Pasadena, Texas, 77504, United States
East Texas Medical Center - Cancer Institute
Tyler, Texas, 75701, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center
St. George, Utah, 84770, United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201, United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498, United States
Green Mountain Oncology Group
Rutland, Vermont, 05701, United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908, United States
Virginia Baptist Hospital
Lynchburg, Virginia, 24503, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
Deaconess Medical Center
Spokane, Washington, 99210-0248, United States
Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, 53713, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
St. Joseph's Hospital
Milwaukee, Wisconsin, 53210, United States
Columbia Hospital
Milwaukee, Wisconsin, 53211, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, K1Y 4K7, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (21)
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.
PMID: 21720747BACKGROUNDRoach 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.
BACKGROUNDMichalski 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.
PMID: 22633552RESULTTucker 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.
PMID: 22342302RESULTTucker 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.
PMID: 22673726RESULTTucker SL, Thames HD, Michalski JM, Bosch WR, Mohan R, Winter K, Cox JD, Purdy JA, Dong L. Estimation of alpha/beta 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.
PMID: 21377288RESULTValicenti 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.
PMID: 21414514RESULTMichalski 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.
PMID: 19577865RESULTTucker 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.
PMID: 20598811RESULTCheung 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.
RESULTTucker 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.
RESULTValicenti 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.
RESULTMichalski 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. doi: 10.1016/j.ijrobp.2004.11.028.
PMID: 15936549RESULTMichalski 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. doi: 10.1016/S0360-3016(03)01578-5.
PMID: 14967428RESULTRoach 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. doi: 10.1016/j.ijrobp.2004.05.026.
PMID: 15590164RESULTMichalski 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. doi: 10.1016/s0360-3016(03)00072-5.
PMID: 12694838RESULTMichalski 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.
RESULTValicenti 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. doi: 10.1016/s0360-3016(03)00640-0.
PMID: 14529764RESULTMichalski 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. doi: 10.1016/s0360-3016(99)00443-5.
PMID: 10661346RESULTRoach 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.
RESULTMcDonald AM, DeMora L, Yang ES, Hoyle JM, Lenzie A, Williams GR, Michalski JM, Yee D, Bahary JP, Den RB, Roach M 3rd, Dess R, Mishra MV, Valicenti RK, Lau HY, Marcrom SR, Souhami L, Mendez LC, Chen Y, Doncals DE, Pugh SL, Feng FY, Sandler HM. Body composition and mortality in men receiving prostate radiotherapy: A pooled analysis of NRG/RTOG 9406 and NRG/RTOG 0126. Cancer. 2023 Mar 1;129(5):685-696. doi: 10.1002/cncr.34596. Epub 2022 Dec 29.
PMID: 36579470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James D. Cox, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
May 26, 2004
Study Start
May 1, 1994
Primary Completion
March 1, 2004
Study Completion
November 1, 2013
Last Updated
January 10, 2020
Record last verified: 2015-03