Study Stopped
Study closed by IRB because a Continuing Review and/or Close-Out have not been submitted. Study closed by IRB
Prospective Evaluation of Intrafractional and Interfractional Cervical Motion During External Beam Radiation for Intact Cervical Cancer by the Calypso® 4D Localization System™
2 other identifiers
observational
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 21, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedOctober 24, 2013
October 1, 2013
2.5 years
May 21, 2009
October 23, 2013
Conditions
Keywords
Eligibility Criteria
Stage IB-IV Cervical cancer patients
You may qualify if:
- Stage IB-IVA Cervical Squamous cell carcinoma
- Karnofsky Performance Score 60-100
You may not qualify if:
- Other histologies
- Karnofsky Performance Score \< 60
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rossi, MD
Emory University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 21, 2009
First Posted
May 22, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2011
Last Updated
October 24, 2013
Record last verified: 2013-10