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Image Guided Radiation Therapy For Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433706
First Posted: February 12, 2007
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Procedure: Control position by 3DOBI before the fraction Procedure: Standard imaging Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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).

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)

Enrollment: 470
Study Start Date: June 2007
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control position by 3DOBI daily Procedure: Control position by 3DOBI before the fraction
Active Comparator: Standard imaging Procedure: Standard imaging

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433706


Locations
France
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Investigators
Principal Investigator: Renaud DE CREVOISIER, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00433706     History of Changes
Other Study ID Numbers: CSET 1248
IGRT-P
First Submitted: February 8, 2007
First Posted: February 12, 2007
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Prostate adenocarcinoma treated by radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases