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

This study has been withdrawn prior to enrollment.
(

Study closed by IRB because a Continuing Review and/or Close-Out have not been submitted.

Study closed by IRB

)
Sponsor:
Information provided by (Responsible Party):
Peter J. Rossi, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00907634
First received: May 21, 2009
Last updated: October 23, 2013
Last verified: October 2013
  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:


Further study details as provided by Emory University:

Enrollment: 0
Study Start Date: February 2009
Primary Completion Date: August 2011 (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
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: NCT00907634

Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Peter Rossi, MD Emory University
  More Information

No publications provided

Responsible Party: Peter J. Rossi, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00907634     History of Changes
Other Study ID Numbers: IRB00013078, EmoryCervicalMotion
Study First Received: May 21, 2009
Last Updated: October 23, 2013
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 July 26, 2014