NCT00800644

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

12.1 years

First QC Date

December 1, 2008

Last Update Submit

January 9, 2020

Conditions

Cervical CancerEndometrial CancerVaginal Cancer

Keywords

Cervical CancerEndometrial CancerVaginal CancerCervixEndometrialX-rayComputed tomographyMagnetic resonance imagingVaginaPelvic radiation therapyBone densityBone mineral density testPelvic fracturesGynecologic OncologyBone turnover

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Bone Mineral Density (BMD)

    2 years

Secondary Outcomes (1)

  • Incidence of pelvic fractures incidence in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer

    Within 2 years of treatment completion

Study Arms (1)

Evaluation Group

Bone Mineral Density Test + MRI or CT + Blood Test

Procedure: CT or MRI + Blood Test

Interventions

CT or MRI + Blood TestPROCEDURE

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.

Also known as: x-ray, computed tomography, magnetic resonance imaging
Evaluation Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cervical, endometrial, or vaginal cancer patients who will receive extended field radiation, brachytherapy, or pelvic radiation therapy.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Salcedo MP, Sood AK, Jhingran A, Eifel PJ, Klopp AH, Iyer RB, Fellman BM, Jimenez C, Schmeler KM. Pelvic fractures and changes in bone mineral density after radiotherapy for cervical, endometrial, and vaginal cancer: A prospective study of 239 women. Cancer. 2020 Jun 1;126(11):2607-2613. doi: 10.1002/cncr.32807. Epub 2020 Mar 3.

    PMID: 32125711DERIVED

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsVaginal NeoplasmsHip Fractures

Interventions

Magnetic Resonance SpectroscopyHematologic TestsX-Rays

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVaginal DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Kathleen Schmeler, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2008

First Posted

December 2, 2008

Study Start

November 5, 2008

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

US(1)