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Trial record 5 of 358 for:    vaginal cancer

Pelvic Fractures and Radiation Therapy for Cervical Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00800644
First received: December 1, 2008
Last updated: March 28, 2016
Last verified: March 2016
  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 participants 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:


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 2017 (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:
  • x-ray
  • computed tomography
  • magnetic resonance imaging

Detailed 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800644

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Kathleen Schmeler, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
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: March 28, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cervical Cancer
Endometrial Cancer
Vaginal Cancer
Vagina
Gynecologic Oncology
Cervix
Endometrial
X-ray
Computed tomography
Magnetic resonance imaging
Pelvic radiation therapy
Bone density
Bone mineral density test
Pelvic fractures
Bone turnover

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vaginal Diseases
Hip Fractures
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 27, 2016