Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer

Completed

Conditions studied: Cervical Cancer

In brief

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 (Positron emission tomography (PET) and magnetic resonance imaging (MRI) and computed tomography (CT)).

Key facts

Study ID

NCT00500435

Run by

M.D. Anderson Cancer Center

People needed

65

Starts

2003-10-01

Expected to finish

2011-05-01

Last updated by the study team

2012-03-26

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 computed tomography (CT) or magnetic resonance imaging (MRI) scan of the abdomen and pelvis.
• Patients must sign an IRB approved informed consent.
• Patients with adequate bone marrow, renal and hepatic function: White Blood Count (WBC) >/= 3,000 cells/mcl, Platelets >/= 100,000/mcl, Creatinine </= 2.0 mg%, Bilirubin </= 1.5 x the upper limit of normal and Serum glutamic pyruvic transaminase (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.

You may not qualify if…

• 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.

Where it is running

• Lyndon Baines Johnson General Hospital — Houston, Texas, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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