Cervical Cancer Clinical Trial
Official title:
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
Verified date | September 2017 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 8, 2017 |
Est. primary completion date | September 8, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. Patients must have no evidence of metastatic disease outside of the pelvis. 3. Patients must have a Karnofsky Performance Status of >60. 4. The patient must be able to understand the protocol and sign a study-specific informed consent. . Exclusion Criteria: 1. Karnofsky Performance Status < 60. 2. Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis. 3. Obese patients who exceed the size limits of hte treatment table or CT scanner. 4. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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