Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT00003734
Last Updated: 2016-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
276 participants
INTERVENTIONAL
1998-12-31
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.
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Detailed Description
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OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive triptorelin IM once a month and oral flutamide three times daily with meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients randomized to arm II receive this therapy regimen for 8 months. All patients then undergo radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months after radiotherapy.
PROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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flutamide
triptorelin
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except nonmelanoma skin cancer No other uncontrolled illness that would prevent compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior or other concurrent hormonal therapy Radiotherapy: Not specified Surgery: No prior treatment other than transurethral prostatectomy No prior orchiectomy
18 Years
120 Years
MALE
No
Sponsors
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St. Luke's Hospital, Ireland
OTHER
Principal Investigators
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John Gerard Armstrong, MD, MB, MRCPI
Role: STUDY_CHAIR
Saint Luke's Hospital
Locations
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Cork University Hospital
Cork, , Ireland
Letterkenny Hospital
Donnegal, , Ireland
St. Vincent's Hospital
Dublin, , Ireland
Saint Luke's Hospital
Dublin, , Ireland
Mater Misericordiae Hospital
Dublin, , Ireland
Adelaide and Meath Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
Bon Secours Hospital
Galway, , Ireland
Galway University Hospital
Galway, , Ireland
Regional Hospital - Limerick
Limerick, , Ireland
Sligo General
Sligo, , Ireland
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, United Kingdom
Countries
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References
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Armstrong JG, Gillham CM, Dunne MT, Fitzpatrick DA, Finn MA, Cannon ME, Taylor JC, O'Shea CM, Buckney SJ, Thirion PG. A randomized trial (Irish clinical oncology research group 97-01) comparing short versus protracted neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):35-45. doi: 10.1016/j.ijrobp.2010.04.065. Epub 2010 Aug 25.
Other Identifiers
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ICORG-97-01
Identifier Type: -
Identifier Source: secondary_id
EU-98060
Identifier Type: -
Identifier Source: secondary_id
CDR0000066849
Identifier Type: -
Identifier Source: org_study_id
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