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Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer

Open (Enrolling)
Cervical Cancer, Endometrial Cancer, Vaginal Cancer

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Trial Information

Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer

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.

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

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Change in Patient Bone Mineral Density (BMD)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Kathleen Schmeler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Vaginal Cancer
  • 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
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Adenoma



UT MD Anderson Cancer Center Houston, Texas  77030