Pelvic Fractures and Radiation Therapy for Cervical Cancer

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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