Brief Title
Pelvic Fractures and Radiation Therapy for Cervical Cancer
Official Title
Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer
Brief Summary
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 you
more likely to break a bone.
Detailed Description
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
Primary Outcome
Change in Patient Bone Mineral Density (BMD)
Secondary Outcome
Incidence of pelvic fractures incidence in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer
Condition
Cervical Cancer
Intervention
CT or MRI + Blood Test
Study Arms / Comparison Groups
Evaluation Group
Description: Bone Mineral Density Test + MRI or CT + Blood Test
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
239
Start Date
November 5, 2008
Completion Date
November 30, 2020
Primary Completion Date
November 30, 2020
Eligibility Criteria
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.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Kathleen Schmeler, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00800644
Organization ID
2008-0023
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Study Sponsor
Kathleen Schmeler, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
January 2020