Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00500435

Purpose

Primary Objectives:

To determine the feasibility of performing an extraperitoneal laparoscopic lymphadenectomy in patients with stage IB2-IVA cervical carcinoma who are dispositioned to undergo radiotherapy and concurrent chemotherapy.
To document intraoperative and postoperative complications in patients undergoing extraperitoneal laparoscopic lymphadenectomy.
To determine the rate of lymph node metastases in the para-aortic region in patients with stage IB2-IVA cervical cancer.
To correlate histopathological findings in the para-aortic lymph nodes with preoperative imaging studies (PET and CT or MRI).

Condition	Intervention
Cervical Cancer	Procedure: Extraperitoneal Laparoscopic Lymphadenectomy

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Pilot Study of Laparoscopic Extraperitoneal Lymph Node Dissection in Patients With Locally Advanced Cervical Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if it is feasible to perform a procedure called an "extraperitoneal laparoscopic lymphadenectomy" in patients with stage IB2-IVA cervical cancer who will be treated with a combination of radiation therapy and chemotherapy. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the complications associated with this procedure and the location and number of lymph nodes removed during the procedure that contain cancer. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	70
Study Start Date:	October 2003
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients diagnosed with cervical cancer.	Procedure: Extraperitoneal Laparoscopic Lymphadenectomy A laparoscope is used to find and remove the para aortic lymph nodes in the abdomen. This may help to find cancer in the lymph nodes that cannot be detected using standard techniques.

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Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with stage IB2-IVA cervical cancer.

Criteria

Inclusion Criteria:

Patients with stage IB2-IVA cervical cancer who are candidates for treatment with radiotherapy and concurrent chemotherapy.
Patients with biopsy-proven cervical carcinoma, any histology.
Patients must have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on the preoperative CT or MRI scan of the abdomen and pelvis.
Patients must sign an IRB approved informed consent.
Patients with adequate bone marrow, renal and hepatic function: WBC >/= 3,000 cells/mcl, Platelets >/= 100,000/mcl, Creatinine </= 2.0 mg%, Bilirubin </= 1.5 x the upper limit of normal and SGPT </= 3 x the upper limit of normal.
Zubrod Performance Status of 0, 1, or 2.
Patients must be suitable candidates for surgery.
Patients who had a PET/CT scan prior to study entry are eligible if a) the study was done within 4 weeks of surgery, and b) they have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on either a preoperative CT or MRI scan of the abdomen and pelvis.

Exclusion Criteria:

Patients who have had prior retroperitoneal surgery.
Patients who have received prior pelvic or abdominal radiotherapy.
Patients known to have upper abdominal intraperitoneal disease or evidence of ovarian metastases.
Patients who are pregnant.
Patients with evidence of distant metastases on chest x-ray, CT or MRI scan or by physical examination.
Patients with contraindications to laparoscopy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500435

Contacts

Contact: Jacalyn B. Gano, RN

713-794-1422

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Pedro Ramirez, MD
Lyndon Baines Johnson General Hospital	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Pedro Ramirez, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Pedro Ramirez, MD/Associate Professor )
Study ID Numbers:	ID03-0098
Study First Received:	July 10, 2007
Last Updated:	December 6, 2008
ClinicalTrials.gov Identifier:	NCT00500435 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cervical Cancer
Laparoscopy
Lymph Node Dissection
Extraperitoneal Laparoscopic Lymphadenectomy

ClinicalTrials.gov processed this record on July 06, 2009