MDACC Study Summary 2008-0023

Study Summary
No. 2008-0023:.......Cervix; Endometrial; Vagina......Kathleen Schmeler......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2008-0023

Study Title:	Evaluation of bone density and pelvic fractures in women undergoing definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer

Physician

New Patient Referral



Name:	Kathleen Schmeler	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3518 Contact us about clinical trials

General Information



Disease Group:	Cervix Endometrial Vagina	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients must return for follow-up visits 3 months, 1year, and 2 years following the completion of therapy. The patients would be scheduled for follow-up visits at these intervals as part of normal post-treatment care.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary Objective:

1. To estimate the incidence of pelvic fractures in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer.
Secondary Objectives:

1. To estimate the association of the following risk factors: age at cancer diagnosis, menopausal status and body mass index (BMI) with the incidence of pelvic fracture.
Exploratory Objectives:

Study Status Information



Study Activation / Registration Date:	09/05/2008

IRB Review and Approval Date:	06/24/2008

Study Type:	Observational

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00800644
Study Information on Clinical Trials Registry (clinicaltrials.gov)