Image Guided Radiation Therapy For Prostate Cancer
Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer
2 other identifiers
interventional
470
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Jun 2007
Typical duration for phase_3 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedDecember 13, 2016
December 1, 2016
5.3 years
February 8, 2007
December 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.
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).
Secondary Outcomes (4)
Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)
Cost comparison and cost/effectiveness analysis
2 and 5 years clinical relapse free survival rates
Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)
Study Arms (2)
Control position by 3DOBI daily
EXPERIMENTALStandard imaging
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- prostate adenocarcinoma
- intermediate / high risk group
- N0 or N -
- treatment by conformal radiotherapy (including or not IMRT), with or without androgen deprivation
You may not qualify if:
- pelvic irradiation
- metal objects in the pelvis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renaud DE CREVOISIER, MD
Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2007
First Posted
February 12, 2007
Study Start
June 1, 2007
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
December 13, 2016
Record last verified: 2016-12