Intensity Modulated Radiotherapy (IMRT) for the Pelvis Post-Hysterectomy
Pilot Study of Intensity Modulated Radiotherapy (IMRT) to Pelvis Post-Hysterectomy With Analysis of Clinical Target Volume Motion and Relation to Position and Volume of Bladder and Rectum During Course of Radiotherapy for Use in Optimization of Margin Size
1 other identifier
observational
24
1 country
1
Brief Summary
The goal of this clinical research study is to use CT scans to find any changes in position of the vagina and pelvic lymph node areas during the course of IMRT radiation therapy. Treatment can then be adjusted in order to "spare" as much normal tissue as possible during radiation therapy. Another goal is to study the side effects of IMRT radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2003
CompletedFirst Submitted
Initial submission to the registry
July 26, 2007
CompletedFirst Posted
Study publicly available on registry
July 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2017
CompletedSeptember 12, 2017
September 1, 2017
14.5 years
July 26, 2007
September 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum variations in position of the vagina and lymph node regions caused by bladder filling and emptying
2 Years (every 3 months for first year and 4 months for second year)
Secondary Outcomes (1)
Day-to-day variations in position of vaginal vault and pelvic lymph node regions
During a 5-week course of intensity modulated pelvic radiation therapy
Study Arms (1)
CT Scan + IMRT Radiation Therapy
Interventions
CT Scans: Twice a week during the 5 weeks of radiation treatment.
Eligibility Criteria
Women treated with a hysterectomy for carcinoma of the uterine cervix or endometrium who require post-operative radiation or chemoradiation therapy because of positive pelvic lymph nodes or other high-risk local findings.
You may qualify if:
- Patients who have been treated with a hysterectomy for carcinoma of the uterine cervix or endometrium who require post-operative radiation or chemoradiation therapy because of positive pelvic lymph nodes or other high-risk local findings.
- Patients must have no evidence of metastatic disease outside of the pelvis.
- Patients must have a Karnofsky Performance Status of \>60.
- The patient must be able to understand the protocol and sign a study-specific informed consent. .
You may not qualify if:
- Karnofsky Performance Status \< 60.
- Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
- Obese patients who exceed the size limits of hte treatment table or CT scanner.
- Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia J. Eifel, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2007
First Posted
July 30, 2007
Study Start
March 5, 2003
Primary Completion
September 8, 2017
Study Completion
September 8, 2017
Last Updated
September 12, 2017
Record last verified: 2017-09