Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
NCT ID: NCT00004054
Last Updated: 2020-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
397 participants
INTERVENTIONAL
2000-01-31
2013-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
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Detailed Description
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* Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel, estramustine, and etoposide, in terms of overall and disease-free survival, biochemical and local control, and freedom from distant metastasis, in patients with localized high-risk prostate cancer.
* Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms.
All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy.
* Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for approximately 20 more months after radiotherapy is completed.
* Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Chemotherapy repeats every 21 days for 4 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,440 patients will be accrued for this study within 6 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hormones and RT
Androgen suppression (AS) (Luteinizing hormone releasing hormone agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
bicalutamide
Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
flutamide
Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
Luteinizing hormone releasing hormone [LHRH] agonist
Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months
Radiation therapy
Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.
Hormones and RT plus Chemotherapy
AS (LHRH agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide \[Casodex\] or flutamide \[Eulexin\]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin \[Coumadin®\]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
bicalutamide
Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
estramustine phosphate sodium
280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles
etoposide
50 mg/m\^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles
flutamide
Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
paclitaxel
135 mg/m\^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles
Radiation therapy
Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.
warfarin
To keep international normalized ratio (INR) \> 1.5 and \< 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy
Interventions
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bicalutamide
Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
estramustine phosphate sodium
280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles
etoposide
50 mg/m\^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles
flutamide
Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
paclitaxel
135 mg/m\^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles
Luteinizing hormone releasing hormone [LHRH] agonist
Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months
Radiation therapy
Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.
warfarin
To keep international normalized ratio (INR) \> 1.5 and \< 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven prostate cancer at high risk for relapse as determined by either of the following:
* Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T stage)
* Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 ng/mL
* Negative lymph nodes
* No metastatic disease
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Zubrod 0 or 1
Life expectancy:
* Not specified
Hematopoietic:
* White blood cell (WBC) count of at least 3,000/mm\^3
* Platelet count at least 130,000/mm\^3
* Hemoglobin at least 11.4 g/dL
Hepatic:
* Aspartate aminotransferase (AST) no greater than 2 times upper limit of normal
Renal:
* Creatinine no greater than 2.5 mg/dL
Other:
* No other invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer
* No major medical or psychiatric illness that would preclude study participation
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 5 years since prior chemotherapy
Endocrine therapy:
* At least 60 days since prior finasteride for prostatic hypertrophy
* At least 90 days since prior testosterone
* No more than 30 days since initiation of prior pharmacologic androgen ablation for prostate cancer
Radiotherapy:
* No prior pelvic radiotherapy
* No concurrent intensity-modulated radiotherapy
Surgery:
* No prior radical prostatectomy
* No prior cryosurgery for prostate cancer
* No prior orchiectomy
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Howard M. Sandler, MD
Role: STUDY_CHAIR
University of Michigan Rogel Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Mount Diablo Medical Center
Concord, California, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
Baptist Hospital of Miami
Miami, Florida, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States
Ball Memorial Hospital Cancer Center
Muncie, Indiana, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Anne Arundel Oncology Center
Annapolis, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Marquette General Hospital
Marquette, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
South Jersey Regional Cancer Center
Millville, New Jersey, United States
Atlantic City Medical Center
Pomona, New Jersey, United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital
Akron, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Wellspan Health - York Cancer Center
York, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Countries
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References
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Rosenthal SA, Bae K, Pienta KJ, Sobczak ML, Asbell SO, Rajan R, Kerlin KJ, Michalski JM, Sandler HM; Radiation Therapy Oncology Group Trial 9902. Phase III multi-institutional trial of adjuvant chemotherapy with paclitaxel, estramustine, and oral etoposide combined with long-term androgen suppression therapy and radiotherapy versus long-term androgen suppression plus radiotherapy alone for high-risk prostate cancer: preliminary toxicity analysis of RTOG 99-02. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):672-8. doi: 10.1016/j.ijrobp.2008.05.020. Epub 2008 Nov 5.
Rosenthal SA, Hunt D, Sartor AO, Pienta KJ, Gomella L, Grignon D, Rajan R, Kerlin KJ, Jones CU, Dobelbower M, Shipley WU, Zeitzer K, Hamstra DA, Donavanik V, Rotman M, Hartford AC, Michalski J, Seider M, Kim H, Kuban DA, Moughan J, Sandler H. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902. Int J Radiat Oncol Biol Phys. 2015 Oct 1;93(2):294-302. doi: 10.1016/j.ijrobp.2015.05.024. Epub 2015 Jul 21.
Nguyen PL, Huang HR, Spratt DE, Davicioni E, Sandler HM, Shipley WU, Efstathiou JA, Simko JP, Pollack A, Dicker AP, Roach M, Rosenthal SA, Zeitzer KL, Mendez LC, Hartford AC, Hall WA, Desai AB, Rabinovitch RA, Peters CA, Rodgers JP, Tran P, Feng FY. Analysis of a Biopsy-Based Genomic Classifier in High-Risk Prostate Cancer: Meta-Analysis of the NRG Oncology/Radiation Therapy Oncology Group 9202, 9413, and 9902 Phase 3 Randomized Trials. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):521-529. doi: 10.1016/j.ijrobp.2022.12.035. Epub 2022 Dec 31.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
Other Identifiers
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CDR0000067250
Identifier Type: -
Identifier Source: secondary_id
RTOG-9902
Identifier Type: -
Identifier Source: org_study_id
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