Pelvic Fractures and Radiation Therapy for Cervical Cancer
This study is currently recruiting participants.
Verified January 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00800644
First received: December 1, 2008
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Endometrial Cancer Vaginal Cancer |
Procedure: CT or MRI + Blood Test |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer |
Resource links provided by NLM:
MedlinePlus related topics:
Benign Tumors
Bone Density
CT Scans
Cancer
Cervical Cancer
Fractures
MRI Scans
Minerals
Vaginal Cancer
X-Rays
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Change in Patient Bone Mineral Density (BMD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Evaluation Group
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. Other Names:
|
Detailed Description:
If you agree to take part in this study, the following tests and procedures will be performed before radiation therapy, and again 3 months, 1 year, and 2 years after you complete radiation:
- 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 will have either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan of the pelvis as part of your standard of care. The type of scan used will be decided by your doctor. 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.
- Before you start treatment, blood (about 2 to 3 teaspoons) will be drawn for tests to measure the level of vitamin D, calcium, phosphorus, and parathyroid hormone (PTH).
When you join the study, 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.
Length of Study:
You will be off study 2 years after you complete radiation.
This is an investigational study. Up to 300 women will take part in the study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Cervical, endometrial, or vaginal cancer patients who will receive extended field radiation, brachytherapy, or pelvic radiation therapy.
Criteria
Inclusion Criteria:
- Patients with histologically confirmed primary or recurrent cervical , endometrial or vaginal cancer. All stages, grades and histologic subtypes will be eligible except neuroendocrine.
- 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.
- Patients must sign an approved informed consent document.
Exclusion Criteria:
- Patients undergoing palliative intent radiation therapy for advanced disease.
- Patients who received prior radiation to the pelvis.
- Patients with an existing pelvic fracture within the proposed radiation field.
- Patients unwilling or unable to provide informed consent for the study.
- Patients with bone metastases.
- Neuroendocrine features present.
- Patients weighing more than 300 lbs are excluded as they cannot be adequately studied in axial skeleton with current bone mineral density software.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800644
Contacts
| Contact: Kathleen Schmeler | 713-745-3518 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Kathleen Schmeler, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Kathleen Schmeler, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00800644 History of Changes |
| Other Study ID Numbers: | 2008-0023 |
| Study First Received: | December 1, 2008 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Cervical Cancer Endometrial Cancer Vaginal Cancer Cervix Endometrial X-ray Computed tomography Magnetic resonance imaging |
Vagina Pelvic radiation therapy Bone density Bone mineral density test Pelvic fractures Gynecologic Oncology Bone turnover |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Vaginal Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Vaginal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013