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A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE


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 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.

Inclusion 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: WBC 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James D. Cox, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000063854

NCT ID:

NCT00002602

Start Date:

May 1994

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Kaplan Cancer CenterNew York, New York  10016
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Hurley Medical CenterFlint, Michigan  48503
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Henry Ford HospitalDetroit, Michigan  48202
Marshfield ClinicMarshfield, Wisconsin  54449
Medical College of WisconsinMilwaukee, Wisconsin  53226
MBCCOP - University of South AlabamaMobile, Alabama  36688
Alabama Oncology, LLCMontgomery, Alabama  36106-2801
Radiation Oncology Associates of West AlabamaTuscallosa, Alabama  35401
Providence Cancer Therapy CenterAnchorage, Alaska  99508
Mount Diablo Medical CenterConcord, California  94524-4110
California Cancer CenterFresno, California  93720
Saint Agnes Cancer CenterFresno, California  93720
Glendale Memorial Hospital and Health CenterGlendale, California  91204
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Loma Linda University Medical CenterLoma Linda, California  92354
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Cancer Care CenterPomona, California  91767
Radiation Oncology Center - SacramentoSacramento, California  95816
O'Connor HospitalSan Jose, California  95128
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
Stanford UniversityStanford, California  94305
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Bridgeport HospitalBridgeport, Connecticut  06610
Whittingham Cancer CenterNorwalk, Connecticut  06856
Halifax Medical CenterDaytona Beach, Florida  32114
Radiation Therapy Associates - Fort MyersFort Myers, Florida  33901
University of Florida Health Science CenterGainesville, Florida  32610-0296
Health First Holmes Regional Medical CenterMelbourne, Florida  32901
Baptist Hospital of MiamiMiami, Florida  33176-2197
Florida Radiation Oncology GroupOrange Park, Florida  32073
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
West Florida Cancer Institute - PensacolaPensacola, Florida  32514
Bayfront Medical CenterSaint Petersburg, Florida  33701
Sarasota Radiation and Medical Oncology CenterSarasota, Florida  34233
Medical Center/John B. Amos Community Cancer CenterColumbus, Georgia  31902
InterCommunity Cancer Center at RomeRome, Georgia  30161
Northwest Community HospitalArlington Heights, Illinois  60005
Northwestern Memorial HospitalChicago, Illinois  60611
Ingalls Memorial HospitalHarvey, Illinois  60426
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Central IllinoisSpringfield, Illinois  62526
St. John's Medical CenterAnderson, Indiana  46016
Clarion Health Partners Inc.Indianapolis, Indiana  46206-1367
Community Hospitals of Indianapolis - Regional Cancer CenterIndianapolis, Indiana  46219
Ball Memorial HospitalMuncie, Indiana  47303-3499
Memorial Hospital of South BendSouth Bend, Indiana  46601
St. Joseph's Radiation Oncology CenterSouth Bend, Indiana  46617
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Louisville Radiation OncologyLouisville, Kentucky  40215
Merle M. Mahr Cancer CenterMadisonville, Kentucky  42431
Western Baptist HospitalPaducah, Kentucky  42001
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Romagosa Radiation Oncology CenterLafayette, Louisiana  70501
Tulane University School of MedicineNew Orleans, Louisiana  70112
Maine Medical CenterPortland, Maine  04102
Anne Arundel Oncology CenterAnnapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Harbor Hospital CenterBaltimore, Maryland  21225
Radiation Oncology Affiliates of Maryland, P.A.Baltimore, Maryland  21237
Cape Cod HospitalHyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer CenterFlint, Michigan  48432
Marquette General HospitalMarquette, Michigan  49855
MidMichigan Regional Medical CenterMidland, Michigan  48670
St. Mary's Medical CenterSaginaw, Michigan  48601
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Elliot Regional Cancer CenterManchester, New Hampshire  03103
John F. Kennedy Medical CenterEdison, New Jersey  08818
South Jersey Hospital - MillvilleMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
Saint Joseph Medical CenterAlbuquerque, New Mexico  87102
New York Methodist HospitalBrooklyn, New York  11215-3609
Finger Lakes Radiation Oncology, P.C.Clifton Springs, New York  14432
Beth Israel Medical CenterNew York, New York  10003
Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Vassar Brothers HospitalPoughkeepsie, New York  12601
New York Medical CollegeValhalla, New York  10595
Northeast Medical CenterConcord, North Carolina  28025
Catawba Memorial HospitalHickory, North Carolina  28601
Meritcare Roger Maris Cancer CenterFargo, North Dakota  58122
Akron General Medical CenterAkron, Ohio  44302
Christ HospitalCincinnati, Ohio  45219
University Hospitals of ClevelandCleveland, Ohio  44106
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
St. John Medical CenterTulsa, Oklahoma  74104
CCOP - Columbia River ProgramPortland, Oregon  97213
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Penn State Geisinger Medical CenterDanville, Pennsylvania  17822-2001
Mercy Catholic Medical Center, Mercy Fitzgerald DivisonDarby, Pennsylvania  19023
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Penn State Geisinger Cancer CenterHershey, Pennsylvania  17033
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Veterans Affairs Medical Center - PhiladelphiaPhiladelphia, Pennsylvania  19104
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Wilkes Barre General HospitalWilkes-Barre, Pennsylvania  18764
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
York HospitalYork, Pennsylvania  17315
Roger Williams Medical Center/BUSMProvidence, Rhode Island  02908-4735
CCOP - GreenvilleGreenville, South Carolina  29615
Jackson-Madison County General HospitalJackson, Tennessee  38301
Harrington Cancer CenterAmarillo, Texas  79106
Julie and Ben Rogers Cancer InstituteBeaumont, Texas  77701
University of Texas Medical BranchGalveston, Texas  77555-1329
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Bayshore Medical CenterPasadena, Texas  77504
East Texas Medical Center - Cancer InstituteTyler, Texas  75701
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Green Mountain Oncology GroupRutland, Vermont  05701
Martha Jefferson HospitalCharlottesville, Virginia  22901
Virginia Baptist HospitalLynchburg, Virginia  24503
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Virginia Mason Medical CenterSeattle, Washington  98111
Swedish Cancer InstituteSeattle, Washington  98104
Deaconess Medical CenterSpokane, Washington  99210-0248
Yakima Valley Memorial HospitalYakima, Washington  98902
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical FoundationLa Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Southern Wisconsin Radiotherapy CenterMadison, Wisconsin  53713
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Columbia HospitalMilwaukee, Wisconsin  53211
St. Joseph's HospitalMilwaukee, Wisconsin  53210
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Southeastern Wisconsin Regional Cancer CenterRacine, Wisconsin  53405
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Schiffler Cancer CenterWheeling, West Virginia  26003
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
UNIMED Medical CenterMinot, North Dakota  58701