Image Guided Radiation Therapy For Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00433706
First received: February 8, 2007
Last updated: September 11, 2007
Last verified: September 2007
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Estimated Enrollment: 520
Study Start Date: June 2007
Estimated Study Completion Date: September 2007
  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433706

Contacts
Contact: Renaud DE CREVOISIER, MD 00 33 1 42 11 45 66 renaud.de.crevoisier@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Renaud DE CREVOISIER, MD    00 33 142 11 45 66    renaud.de.crevoisier@igr.fr   
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

No publications provided

ClinicalTrials.gov Identifier: NCT00433706     History of Changes
Other Study ID Numbers: CSET 1248, IGRT-P
Study First Received: February 8, 2007
Last Updated: September 11, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 18, 2014