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Trial record 68 of 1451 for:    prostate cancer AND radiation

Radiation Therapy in Treating Patients With Stage II 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: NCT00033631
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : February 8, 2017
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: 70.2 Gy 3D-CRT/IMRT Radiation: 79.2 Gy 3D-CRT/IMRT Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy.
  • Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
  • Compare the probability of tumor control and normal tissue complications in patients treated with these regimens.
  • Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens.
  • Compare the quality of life, including sexual function, of patients treated with these regimens.
  • Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but < 20 ng/mL vs Gleason score 7, PSA < 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days).
  • Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days).

Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Study Start Date : March 2002
Actual Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: 70.2 Gy
70.2 Gy 3D-CRT/IMRT
Radiation: 70.2 Gy 3D-CRT/IMRT
Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
Other Names:
  • 3D conformal radiation therapy
  • intensity modulated radiation therapy

Experimental: 79.2 Gy
79.2 Gy 3D-CRT/IMRT
Radiation: 79.2 Gy 3D-CRT/IMRT
Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
Other Names:
  • 3D conformal radiation therapy
  • intensity modulated radiation therapy




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. ]
    Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.


Secondary Outcome Measures :
  1. Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition [ Time Frame: From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years. ]
    Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.

  2. Disease Specific Survival [ Time Frame: From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint. ]
    Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.

  3. Local Progression [ Time Frame: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. ]
    Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.

  4. Distant Metastases [ Time Frame: From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. ]
    Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.

  5. Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity [ Time Frame: From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint ]
    Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0

  6. Erectile Function by International Index of Erectile Function (IIEF) [ Time Frame: From randomization to 5 years. ]
  7. Global Quality of Life (QOL) by Spitzer QOL Index (SQLI) [ Time Frame: From randomization to 5 years. ]
  8. Quality Adjusted Survival by SQLI [ Time Frame: From randomization to 5 years. ]
    This analysis will not be done because there was no difference in survival between the two treatment arms.

  9. Tumor Control Probability [ Time Frame: From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis. ]
  10. Normal Tissue Complication Probability [ Time Frame: From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Clinical stage T1b-T2b
  • Meets one of the following criteria:

    • Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL
    • Gleason score 7 AND PSA < 15 ng/mL
  • No regional lymph node involvement
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
  • No other major medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior cytotoxic chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • At least 3 months since prior finasteride
  • No other prior hormonal therapy, including:

    • Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
    • Antiandrogens (e.g., flutamide or bicalutamide)
    • Estrogens (e.g., diethylstilbestrol)
  • No concurrent (neoadjuvant or adjuvant) hormonal therapy

Radiotherapy:

  • No prior pelvic irradiation or brachytherapy

Surgery:

  • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No prior surgical castration (bilateral orchiectomy)

Other:

  • At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)

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): NCT00033631


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Locations
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United States, California
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Bay Medical
Panama City, Florida, United States, 32401
United States, Illinois
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
Oncology Center at Saint Margaret Mercy Healthcare Center
Hammond, Indiana, United States, 46320
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
United States, Kansas
Providence Medical Center
Kansas City, Kansas, United States, 66112
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Johnson County Radiation Therapy
Overland Park, Kansas, United States, 66210
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Central Maryland Oncology Center
Columbia, Maryland, United States, 21044
United States, Michigan
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Independence Regional Health Center
Independence, Missouri, United States, 64050
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Kansas City Cancer Center at St. Joseph's Medical Mall
Kansas City, Missouri, United States, 64114
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Parvin Radiation Oncology
Kansas City, Missouri, United States, 64116
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
Kansas City, Missouri, United States, 64154
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nevada
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
United States, New Jersey
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States, 08103
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
United States, New York
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Cancer Centers of North Carolina - Raleigh
Raleigh, North Carolina, United States, 27607
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States, 45069
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
MNAP Oncologic Center
Philadelphia, Pennsylvania, United States, 19115
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada, P7B 6V4
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeff M. Michalski, MD Washington University - Saint Louis
Study Chair: James Purdy, Ph.D. UC Davis
Study Chair: Deborah W Bruner, Ph.D. Emory University
Study Chair: Mahul Amin, M.D. Cedars-Sinai

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00033631     History of Changes
Other Study ID Numbers: RTOG-0126
CDR0000069306
First Posted: January 27, 2003    Key Record Dates
Results First Posted: February 8, 2017
Last Update Posted: November 20, 2019
Last Verified: May 2019
Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases