The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study
NCT00452556 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2014-03-19
Summary
The purpose of this study is to see if sequence inversion of Intensity - modulated Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that inverting the traditional sequence of radiotherapy can delay the time to treatment - induced bowel toxicity.
Conditions
- Prostatic Neoplasms
Interventions
- DRUG
-
Weekly
- DRUG
-
Leuprolide Acetate (Eligard®)
2.5 years
- RADIATION
-
Intensity-Modulated Radiotherapy
Standard sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate, followed by irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)
- RADIATION
-
Intensity-Modulated Radiotherapy
Experimental sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate last, irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)first
Sponsors & Collaborators
-
Nova Scotia Cancer Centre
lead OTHER
Principal Investigators
-
Derek R Wilke, MD,MSc,FRCPC · Nova Scotia Cancer Centre, Department of Radiation Oncology, Dalhousie University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-05-31
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- Canada
Study Locations
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