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Image Guided Radiation Therapy For Prostate Cancer

NCT ID: NCT00433706

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Keywords

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Prostate adenocarcinoma treated by radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Control position by 3DOBI daily

Group Type EXPERIMENTAL

Control position by 3DOBI before the fraction

Intervention Type PROCEDURE

Standard imaging

Group Type ACTIVE_COMPARATOR

Standard imaging

Intervention Type PROCEDURE

Interventions

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Control position by 3DOBI before the fraction

Intervention Type PROCEDURE

Standard imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renaud DE CREVOISIER, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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IGRT-P

Identifier Type: -

Identifier Source: secondary_id

CSET 1248

Identifier Type: -

Identifier Source: org_study_id