MDACC Study Summary 2006-0153

Study Summary
No. 2006-0153:.......Cervix......Michael M. Frumovitz......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2006-0153

Study Title:	Histopathologic Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients with Cervical or Endometrial Cancer Undergoing Radical Hysterectomy or Radical Trachelectomy and Pelvic Lymph Node Dissection: A Feasibility Study

Physician

New Patient Referral



Name:	Michael M. Frumovitz	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:	713-792-9599 Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients are seen postoperatively and post radiation therapy as needed.

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable

Description/
Intervention:

The goal of this clinical research study is to find out if the parametrial
nodes are "sentinel" nodes (the lymph nodes believed to be the greatest risk
for the spread of cancer) and if intraoperative lymphatic mapping can identify
"sentinel" lymph nodes in the parametrium (the tissue that is on either side of
the cervix). Identifying these lymph nodes may help to predict the status of
the remaining lymph nodes in the pelvis. This research will also determine if
India Ink is safe to use with the blue dye and radioactive tracer and if it
improves the process of identifying the sentinel nodes.

Study Objectives / Outcomes

Primary Objective

1. To determine whether the parametrial lymph nodes are "sentinel" lymph nodes in patients with cervical or endometrial cancer undergoing radical hysterectomy or radical trachelectomy, pelvic lymph node dissection, and intraoperative lymphatic mapping.

Secondary Objectives

1. To asses the safety of lymphatic mapping with radiocolloid, isosulfan blue, and sterile India ink in patients with cervical or endometrial cancer.

Study Status Information



Study Activation / Registration Date:	02/21/2008

IRB Review and Approval Date:	06/02/2006

Study Type:	Other

Recruitment Status:	Closed

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 who are dispositioned to undergo radical hysterectomy or radical trachelectomy and pelvic lymphadnectomy.

2) No evidence of metastases on computed tomography, magnetic resonance imaging, or PET/CT scan.

3) Patients must be good surgical candidates.

4) Patients who have signed an approved informed consent and authorization permitting release of personal health information.

5) For patients of child-bearing age, a negative serum pregnancy test within 72 hours prior to injection of radiocolloid. Child-bearing potental is defined as not post-menopausal for 12 months or no previous surgical sterilization.

Exclusion Criteria:

1) Patients with known allergies to triphenylmethane compounds or India ink.

2) Patients with a history of retroperitoneal surgery.

3) Patients with a history of pelvic irradiation.

4) Patients who had a cold knife or LEEP cone biopsy within 4 weeks of enrollment.

Links

Registration Number: NCT00631241
Study Information on Clinical Trials Registry (clinicaltrials.gov)