The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study
1 other identifier
interventional
86
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2007
CompletedFirst Posted
Study publicly available on registry
March 27, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 19, 2014
March 1, 2014
9.8 years
March 26, 2007
March 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate if the inversion of sequencing of multi - phase, intensity - modulated radiotherapy (IMRT), for the treatment of patients with high - risk prostate cancer, can improve the delivery of concurrent, weekly Docetaxel chemotherapy, in conc
3 years
Secondary Outcomes (3)
To investigate if the inversion of sequencing of multi - phase IMRT can improve the time to grade 2 or 3 gastrointestinal toxicity.
3 years
total amount of Docetaxel that can be delivered
3 years
quality of life in patients receiving concurrent, weekly Docetaxel chemotherapy, in concert with long - term androgen deprivation (LTAD).
3 years
Study Arms (2)
Standard Radiotherapy Sequence Arm
ACTIVE COMPARATORStandard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last
Experimental Radiotherapy Sequence Arm
EXPERIMENTALExperimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first
Interventions
Weekly
2.5 years
Standard sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate, followed by irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Related Publications (1)
Wilke D, Wood L, Cwajna S, Rutledge R, Hollenhorst H, Bowes D, Patil N, Ago CT, Pignol JP. Sequence Inversion to Facilitate Concurrent Radiotherapy and Systemic Therapy. A Proof of Principle Study in the Setting of a Phase II Randomized Trial in Prostate Cancer. Front Oncol. 2020 Sep 30;10:570660. doi: 10.3389/fonc.2020.570660. eCollection 2020.
PMID: 33102224DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Derek R Wilke, MD,MSc,FRCPC
Nova Scotia Cancer Centre, Department of Radiation Oncology, Dalhousie University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director, Department of Radiation Oncology
Study Record Dates
First Submitted
March 26, 2007
First Posted
March 27, 2007
Study Start
May 1, 2007
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
March 19, 2014
Record last verified: 2014-03