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Prospective Evaluation of Intrafractional and Interfractional Cervical Motion During External Beam Radiation for Intact Cervical Cancer by the Calypso® 4D Localization System™

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00907634
First received: May 21, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

The purpose of this study is to find out how the cervix normally moves during radiation treatment. This study will also evaluate how cervical cancer shrinks during chemotherapy and radiation. By better understanding these two things, the investigators can see if radiation could safely be given in a more focused way in the future.

The investigational portion of this study includes (1) daily cone beam CT scans to confirm transponder placement and evaluate tumor changes during treatment and (2) tracking movement of the cervix during daily radiation treatment.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Evaluation of Intrafractional and Interfractional Cervical Motion During External Beam Radiation for Intact Cervical Cancer by the Calypso® 4D Localization System™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Estimated Enrollment: 10
Study Start Date: April 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stage IB-IV Cervical cancer patients

Criteria

Inclusion Criteria:

  • Stage IB-IVA Cervical Squamous cell carcinoma
  • Karnofsky Performance Score 60-100

Exclusion Criteria:

  • Other histologies
  • Karnofsky Performance Score < 60
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907634

Contacts
Contact: Peter Rossi, MD 404-778-5751 rossi@radonc.emory.org

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Peter Rossi, MD     404-778-5751     rossi@radonc.emory.org    
Principal Investigator: Peter Rossi, MD            
Sub-Investigator: Karen Godette, MD            
Sub-Investigator: Heather G Gatcombe, MD            
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Peter Rossi, MD Emory University
  More Information

No publications provided

Responsible Party: Peter Rossi, MD, Emory University
ClinicalTrials.gov Identifier: NCT00907634     History of Changes
Other Study ID Numbers: EmoryCervicalMotion
Study First Received: May 21, 2009
Last Updated: May 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
cervix
cervical
radiation

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013