Continuous vs intermittent weekly docetaxel in the elderly patient with advanced and hormone-refractory prostate cancer: a randomized phase II study - ND
- Conditions
- Advanced and hormone-refractory prostate cancerMedDRA version: 9.1Level: LLTClassification code 10036909Term: Prostate cancer metastatic
- Registration Number
- EUCTR2008-001632-13-IT
- Lead Sponsor
- EGA ITALIANA PER LA LOTTA CONTRO I TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- Hormone-refractory prostate cancer in biochemical remission following two cycles of chemotherapy with weekly docetaxel
- Age > 70 years
- ECOG PS < 2
- No prior chemotherapy
- No history of other malignancies
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Brain metastases
- Uncontrolled infections
- Heart failure or ischemic heart disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the quality of life in two arms;Secondary Objective: To compare the overall survival<br>To compare the toxicity<br>To compare the saving in drug costs;Primary end point(s): See main objective
- Secondary Outcome Measures
Name Time Method