Cervical CancerNCT00800644
Pelvic Fractures and Radiation Therapy for Cervical Cancer
An observational study of Cervical Cancer and Endometrial Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Vaginal Cancer
- What is being tested?
- CT or MRI + Blood Test
- Type of treatment
- Surgery or procedure
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2008to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cervical, endometrial, or vaginal cancer patients who will receive extended field radiation, brachytherapy, or pelvic radiation therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer
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.
Read the 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.
- Conditions
- Cervical Cancer, Endometrial Cancer, Vaginal Cancer
- Being tested
- CT or MRI + Blood Test
- Keywords
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Vaginal Neoplasms, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT or MRI + Blood TestProcedure or surgery
Also called x-ray, computed tomography, magnetic resonance imaging
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation Group | Bone Mineral Density Test + MRI or CT + Blood Test Receives: Procedure: CT or MRI + Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Bone Mineral Density (BMD)
Measured: 2 years
Secondary outcomes (1)
Incidence of pelvic fractures incidence in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer
Measured: Within 2 years of treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study start5 Nov 2008
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Schmeler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800644
- Sponsor's protocol ID
- 2008-0023
- Status last verified
- Jan 2020
- First submitted
- 1 Dec 2008
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32125711
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer
- ClinicalTrials.gov ID
- NCT00800644
- Acronym / sponsor ID
- 2008-0023
- Conditions
- Cervical Cancer, Endometrial Cancer, Vaginal Cancer
- Keywords
- Cervical Cancer, Endometrial Cancer, Vaginal Cancer, Cervix, Endometrial, X-ray, Computed tomography, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Nov 2008 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation Group | – | Procedure: CT or MRI + Blood TestBone Mineral Density Test + MRI or CT + Blood Test |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cervical, endometrial, or vaginal cancer patients who will receive extended field radiation, brachytherapy, or pelvic radiation therapy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT or MRI + Blood TestAlso: x-ray, computed tomography, magnetic resonance imagingDuring 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. | Procedure or surgery | Evaluation Group |
Primary outcome
Change in Patient Bone Mineral Density (BMD)
Time frame: 2 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 32125711Salcedo 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Cervical Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Schmeler, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Endometrial Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Bone Mineral Density (BMD) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00800644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.