Image Guided Radiation Therapy For Prostate Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 8, 2007

Last Updated Date

September 11, 2007

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

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).

Original Primary Outcome Measures ^†

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).

Change History

Complete list of historical versions of study NCT00433706 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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)

Original Secondary Outcome Measures ^†

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)

Descriptive Information

Brief Title ^†

Image Guided Radiation Therapy For Prostate Cancer

Official Title ^†

Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Prostate Cancer

Intervention ^†

Procedure: Control position by 3DOBI before the fraction

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

520

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: Renaud DE CREVOISIER, MD

00 33 1 42 11 45 66

renaud.de.crevoisier@igr.fr

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00433706

Responsible Party

Secondary IDs ^††

IGRT-P

Study Sponsor ^†

Institut Gustave Roussy

Collaborators ^††

National Cancer Institute, France

Investigators ^†

Principal Investigator:

Renaud DE CREVOISIER, MD

Institut Gustave Roussy

Information Provided By

Institut Gustave Roussy

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.