Pelvic Fractures and Radiation Therapy for Cervical Cancer
This trial is active, not recruiting.
|Conditions||cervical cancer, endometrial cancer, vaginal cancer|
|Treatment||ct or mri + blood test|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||November 2008|
|End date||November 2017|
|Trial size||300 participants|
|Trial identifier||NCT00800644, 2008-0023|
The goal of this study is to estimate how often pelvic fractures occur in women treated with radiation therapy for either newly diagnosed or recurrent cervical, endometrial, or vaginal cancer. The study will also estimate the changes in bone mineral density and the changes in the blood that relate to "bone turnover". High bone turnover can weaken bones and make participants more likely to break a bone.
Bone Mineral Density Test + MRI or CT + Blood Test
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
Female participants of any age.
Inclusion Criteria: 1. Patients with histologically confirmed primary or recurrent cervical , endometrial or vaginal cancer. All stages, grades and histologic subtypes will be eligible except neuroendocrine. 2. Patients treated with definitive radiation therapy. Patients receiving extended field radiation or brachytherapy in addition to pelvic radiation are eligible. Patients treated with surgery, chemotherapy and/or hormonal therapy in addition to radiation therapy are also eligible. 3. Patients must sign an approved informed consent document. Exclusion Criteria: 1. Patients undergoing palliative intent radiation therapy for advanced disease. 2. Patients who received prior radiation to the pelvis. 3. Patients with an existing pelvic fracture within the proposed radiation field. 4. Patients unwilling or unable to provide informed consent for the study. 5. Patients with bone metastases. 6. Neuroendocrine features present. 7. Patients weighing more than 300 lbs are excluded as they cannot be adequately studied in axial skeleton with current bone mineral density software.
|Official title||Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer|
|Principal investigator||Kathleen Schmeler, MD|
|Description||If participant agrees to take part in this study, the following tests and procedures will be performed before radiation therapy: - Participant 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 participant's risk for fractures. During the test, participant will lie on a cushioned table while a mechanical arm-like device will pass over their body. This device will not touch participant. - During participant's routine visits, they may have either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan of the pelvis as part of their standard of care. A PET scan may be done if participant's doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine participant's response to therapy, determine if their 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 participant's medical record. This information will include participant's medical history, their ethnicity, if they have had any bone fractures, if they have a history of bone fractures in their family, and their 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 participant completes radiation: - Participant will have a bone mineral density test. - Participant may have either an MRI or CT scan of the pelvis as part of their standard of care. A PET scan may be done if participant's doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine participant's response to therapy, determine if their 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: Participant will be off study 2 years after they complete radiation. After 2 years and for up to 5 years, results of bone density tests or scans of the pelvis that participant has had 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.|
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