Status:
UNKNOWN
The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study
Lead Sponsor:
Nova Scotia Cancer Centre
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
Phase:
PHASE2
Brief 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 chemothera...
Detailed Description
1.0 Objectives 1.1 Primary objective To investigate if the inversion of sequencing of multi - phase, intensity - modulated radiotherapy (IMRT), for the treatment of patients with high - risk prostat...
Eligibility Criteria
Inclusion
- A histological diagnosis of adenocarcinoma of the prostate
- Life expectancy greater than 5 years.
- ECOG performance status \< 1.
- Signed, written informed consent prior to randomization.
- Any one, or more, of the following criteria:
- TNM stage T2c, T3a or T3b
- Gleason score 8 to 10, as determined by central institutional review.
- PSA \> 20 mcg/L, but \< 50 mcg/L. OR Have a \> 50% chance of recurrence after radical prostatectomy, as predicted by the Kattan Nomogram and
- Post - op PSA \< 1.0 mcg/L.
- Must be able to start protocol treatment within 6 months from date of surgery.
- No evidence of metastasis, as determined by bone scan and Chest x-ray/CT abdomen/pelvis.
- Adequate marrow reserve and end - organ function
- Leukocytes \> 3,000/mcL.
- Absolute neutrophil count \> 1,500/mcL
- Platelets \> 100,000/mcL
- Total bilirubin \< 1.2 x upper limit of normal for the institution.
- AST(SGOT)/ALT(SGPT) greater than 1.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR
- Creatinine clearance \> 60 mL/min using the Crockfort - Gault formula for patients with creatinine levels above institutional normal.
Exclusion
- PSA \> 50 µg/L.
- Previous pelvic radiotherapy
- Sensitivity to Docetaxel chemotherapy.
- Grade 2 or greater NCI CTCAE version 3.0 neuropathy.
- Prior malignancy within the last 5 years, other than prostate cancer, except:
- Patients with adequately treated non - melanoma cutaneous malignancies.
- Patients with a history of a curatively treated malignancy (including patients with superficial bladder cancer) who have not had evidence of recurrence for a minimum of 5 years.
- Patients with a history of hypersensitivity to polysorbate 80.
- Patients with a known history of viral hepatitis (B,C).
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2017
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00452556
Start Date
May 1 2007
End Date
February 1 2017
Last Update
March 19 2014
Active Locations (1)
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1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7