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Pelvic Fractures and Radiation Therapy for Cervical Cancer

NCT00800644UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

M.D. Anderson Cancer Center

Enrollment

239

Start Date

2008-11-05

Completion Date

2020-11-30

Study Type

OBSERVATIONAL

Official Title

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

Interventions

CT or MRI + Blood Test

Conditions

Cervical CancerEndometrial CancerVaginal Cancer

Eligibility

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Change in Patient Bone Mineral Density (BMD)

Time frame: 2 years

Secondary Outcomes

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

Locations

University of Texas MD Anderson Cancer Center, Houston, United States

Linked Papers

2020-03-03

Pelvic fractures and changes in bone mineral density after radiotherapy for cervical, endometrial, and vaginal cancer: A prospective study of 239 women

Background Advances in radiotherapy (RT) have led to improved oncologic outcomes for women with gynecologic cancers; however, the long‐term effects and survivorship implications need further evaluation. The purpose of this study was to determine the incidence of pelvic fractures and changes in bone mineral density (BMD) after pelvic RT. Methods Two hundred thirty‐nine women who had pelvic RT for cervical, endometrial, or vaginal cancer between 2008 and 2015 were prospectively studied. BMD scans and biomarkers of bone turnover were obtained at the baseline and 3 months, 1 year, and 2 years after RT. Imaging studies were assessed for pelvic fractures for up to 5 years. Patients with osteopenia, osteoporosis, or pelvic fractures at any point were referred to the endocrinology service for evaluation and treatment. Results The median age at diagnosis was 51 years; 132 patients (56%) were menopausal. The primary diagnoses were cervical (63.6%), endometrial (30.5%), and vaginal cancer (5.9%). Sixteen patients (7.8%; 95% confidence interval, 4.5%‐12.4%) had pelvic fractures with actuarial rates of 3.6%, 12.7%, and 15.7% at 1, 2, and 3 years, respectively. Fractures were associated with baseline osteoporosis ( P < .001), higher baseline bone‐specific alkaline phosphatase ( P < .001), and older age ( P = .007). The proportion of patients with osteopenia/osteoporosis increased from 50% at the baseline to 58%, 59%, and 70% at 3 months, 1 year, and 2 years, respectively. Conclusions A high proportion of women had significant decreases in BMD after pelvic RT, with 7.8% diagnosed with a pelvic fracture. BMD screening and pharmacologic intervention should be strongly considered for these high‐risk women.

Linked Investigators

Kathleen M Schmeler