Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3N0 Prostate Cancer
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First Received Date ICMJE | April 24, 2008 | ||||||||
Last Updated Date | August 28, 2012 | ||||||||
Start Date ICMJE | August 2012 | ||||||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
To determine whether greater than or equal to 95% of patients who undergo adjuvant hormonal therapy, radiation therapy and docetaxel after a radical prostatectomy can safely tolerate and complete this regimen. [ Time Frame: Approximately 6-8 mos. ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures ICMJE |
To determine whether greater than 95% of patients who undergo adjuvant hormonal therapy, radiation therapy and docetaxel after a radical prostatectomy can safely tolerate and complete this regimen. [ Time Frame: Approximately 6-8 mos. ] [ Designated as safety issue: Yes ] | ||||||||
Change History | Complete list of historical versions of study NCT00669162 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE | |||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3N0 Prostate Cancer | ||||||||
Official Title ICMJE | A Phase I/II Trial of Post-Prostatectomy Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3NO Prostate Cancer | ||||||||
Brief Summary | Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times). |
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Detailed Description | To determine the safety and feasibility of combining post-operative radiation therapy, and hormonal therapy (6 months) and concurrent docetaxel in men with high risk pathologic T2-3N0 prostate cancer after a radical prostatectomy. To obtain preliminary information regarding the efficacy of combining weekly docetaxel with adjuvant radiation therapy and hormonal therapy in men with high risk pathologic T2-3N0 prostate cancer by determining PSA failure free survival. To assess baseline and longitudinal changes in health-related quality of life outcomes during and after therapy (at 3, 6, 12 and 24 months) |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||||||
Intervention ICMJE |
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Study Arm (s) | Experimental: RT, Docetaxel, Hormonal Therapy
Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)
Interventions:
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 25 | ||||||||
Estimated Completion Date | September 2014 | ||||||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||||||
Ages | 18 Years to 85 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00669162 | ||||||||
Other Study ID Numbers ICMJE | 12313 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | University of Kansas | ||||||||
Study Sponsor ICMJE | University of Kansas | ||||||||
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Investigators ICMJE |
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Information Provided By | University of Kansas | ||||||||
Verification Date | August 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |