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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00127088 |
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Date of registration:
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03/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients
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Scientific title:
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A Prospective Phase II of Peri-Operative Docetaxel + Laparoscopic Radical Prostatectomy in Patients With Localized Gleason 7 pT2a-pT2b Adenocarcinoma and a Risk of Relapse After Radical Prostatectomy |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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37 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT00127088 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Karim Fizazi, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients older than 18 years and less than 70 years
- Histologically-proven Gleason 7 adenocarcinoma of the prostate
- pT2a or pT2b disease based on biopsies of the prostate
- More than 2/3 of positive biopsies or 15 = serum PSA <20
- No previous carcinoma, except basal-cell carcinoma of the skin
- Adequate renal function: measured or calculated creatinine clearance> 60 ml/min
- Absolute granulocyte count = 1,500/mm3, platelets = 100,000 mm3, bilirubin = 1.5 fold
the upper normal value
- Signed informed consent.
Exclusion Criteria:
- Patients infected by the Human Immunodeficiency Virus (HIV)
- Contra-indication to general anesthesia or surgery
- Patients who do not fit inclusion criteria
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Procedure: laparoscopic radical prostatectomy
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Drug: docetaxel
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Primary Outcome(s)
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Complete prostate specific antigen (PSA) response rate
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Secondary Outcome(s)
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Overall survival
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Pathological response rate
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Progression free survival
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Toxicity
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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