- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00433706
Image Guided Radiation Therapy For Prostate Cancer
December 12, 2016 updated by: Gustave Roussy, Cancer Campus, Grand Paris
Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer
During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging.
This prostate motion may lead to a mistargeting, which possibly decreases the local control.
On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive.
The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
470
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Villejuif, France, 94805
- Institut Gustave Roussy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- prostate adenocarcinoma
- intermediate / high risk group
- N0 or N -
- treatment by conformal radiotherapy (including or not IMRT), with or without androgen deprivation
Exclusion Criteria:
- pelvic irradiation
- metal objects in the pelvis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control position by 3DOBI daily
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Active Comparator: Standard imaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.
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To validate the optimal strategy of IGRT for prostate adenocarcinoma based on 2 and 5 year-disease free survival rates (events= biochemical failure or death).
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Secondary Outcome Measures
Outcome Measure |
---|
Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)
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Cost comparison and cost/effectiveness analysis
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2 and 5 years clinical relapse free survival rates
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Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Renaud DE CREVOISIER, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
February 8, 2007
First Submitted That Met QC Criteria
February 9, 2007
First Posted (Estimate)
February 12, 2007
Study Record Updates
Last Update Posted (Estimate)
December 13, 2016
Last Update Submitted That Met QC Criteria
December 12, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSET 1248
- IGRT-P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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