Return to List

Study Summary
No. 2007-0723:.......Cervix......Michael M. Frumovitz......Gynecologic Oncology
.
Study Summary Title
Study Summary
Number:		2007-0723
Study Title:Radical Trachelectomy for Women with Early Stage Cervical Cancer
.
Physician New Patient Referral
Name:Michael M. FrumovitzPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-9599
Contact us about clinical trials
.
General Information
Disease Group:CervixSupported By:N/A
Phase of Study:N/AReturn
Visit:		Participants do not need to return to MDACC to participate in this study.
However, if they are coming for follow-up visits for their surgery, they may
answer questionnaires then if they so wish.
Treatment
Agents:		QuestionnaireHome Care:Questionnaires may be sent by mail and answered at home.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		n/a
Description/
Intervention:		The goal of this research study is to learn about quality of life, sexual
functioning, and symptoms in women who have undergone abdominal radical
trachelectomy for cervical cancer.
.
Study Objectives / Outcomes
Primary objective:
    1. To longitudinally assess quality of life, sexual functioning, symptoms, and satisfaction with healthcare decisions in women who have undergone abdominal radical trachelectomy for cervical cancer

Secondary objectives:
    1. To determine long-term fecundity and pregnancy outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer
    2. To determine short- and long-term operative outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer
    3. To determine disease-free and overall survival in women who have undergone abdominal radical trachelectomy for cervical cancer
.
Study Status Information
Study Activation / Registration Date:12/16/2008
IRB Review and Approval Date:12/16/2008
Study Type:Behavioral
Recruitment Status:Open
Projected Accrual:100
.
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) Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.

2) Patients with FIGO stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease.

3) Patients must be suitable candidates for surgery.

4) Patients who have signed an approved Informed Consent

5) Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease

6) Females older than 18 years who are undergoing radical trachelectomy

7) Women must be able to read and write in either Spanish or English
Exclusion Criteria:1) Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix

2) Tumor size greater than 4 cm

3) FIGO stage II-IV disease

4) Patients with a history of pelvic or abdominal radiotherapy

5) Patients who are pregnant

6) Patients with contraindications to surgery

7) Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
.
Links
Registration Number: NCT00813007
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center