The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

NCT00452556 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2014-03-19

No results posted yet for this study

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

Docetaxel

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452556 on ClinicalTrials.gov