Pelvic Fractures and Radiation Therapy for Cervical Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00800644|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2008
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment|
|Cervical Cancer Endometrial Cancer Vaginal Cancer||Procedure: CT or MRI + Blood Test|
If you agree to take part in this study, the following tests and procedures will be performed before radiation therapy:
- You will have a bone mineral density test. A bone mineral density test measures bone loss over time, identifies osteoporosis (a disease of the bones that causes them to be weak and easily breakable) or the risk for developing osteoporosis, and checks your risk for fractures. During the test, you will lie on a cushioned table while a mechanical arm-like device will pass over your body. This device will not touch you.
- During your routine visits, you may have either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan of the pelvis as part of your standard of care. A PET scan may be done if your doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine your response to therapy, determine if your cancer has returned, and to look for broken bones.
- Blood (about 1 tablespoon) will be drawn to test for bone turnover.
- Blood (about 2 to 3 teaspoons) will be drawn for tests to measure the level of vitamin D, calcium, phosphorus, and parathyroid hormone (PTH).
- Researchers will collect information from your medical record. This information will include your medical history, your ethnicity, if you have had any bone fractures, if you have a history of bone fractures in your family, and your use of tobacco and/or alcohol.
At 4 weeks after start of radiation therapy, blood (about 2 to 3 teaspoons) will be drawn to test for bone turnover.
At 3 months, 1 year, and 2 years after you complete radiation:
- You will have a bone mineral density test.
- You may have either an MRI or CT scan of the pelvis as part of your standard of care. A PET scan may be done if your doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine your response to therapy, determine if your cancer has returned, and to look for broken bones.
- Blood (about 2 tablespoons) will be drawn for tests to measure the level of vitamin D and to test for bone turnover.
Length of Study:
You will be off study 2 years after you complete radiation.
After 2 years and for up to 5 years, results of bone density tests or scans of the pelvis that you have outside of this study will be collected.
This is an investigational study.
Up to 300 women will take part in the study. All will be enrolled at MD Anderson.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer|
|Actual Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Bone Mineral Density Test + MRI or CT + Blood Test
Procedure: CT or MRI + Blood Test
During routine visits, a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
Blood (about 1 tablespoon) will be drawn to test for bone turnover.
- Change in Patient Bone Mineral Density (BMD) [ Time Frame: 2 years ]
- Incidence of pelvic fractures incidence in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer [ Time Frame: Within 2 years of treatment completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800644
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kathleen Schmeler, MD||M.D. Anderson Cancer Center|