Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer
Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer
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)).
Currently, the decision about how much radiation should be given to patients with stage
 IB2-IVA cervical cancer is based on direct physical examination, chest x-ray, computed
 tomography (CT) scan, magnetic resonance imaging (MRI) scan, cystoscopy (examination of the
 bladder), proctoscopy (examination of the rectum), and possibly an intravenous pyelogram (a
 test that uses dye to outline the bladder, kidneys, and the tubes that carry urine from the
 kidney to the bladder on an x-ray). Unfortunately, these techniques may not identify cancer
 that has spread to the lymph nodes. Studies have shown that cancer in the lymph nodes is one
 of the most important factors in the return of the cancer. Standard radiation therapy treats
 the lymph nodes in the pelvis area but does not include the lymph nodes in the abdomen
 (called para aortic lymph nodes) . If cancer is present in the lymph nodes in the abdomen and
 it was not detected by the standard techniques, the cancer could be undertreated and the risk
 of the cancer returning would be high.

 Using a surgical procedure called extraperitoneal laparoscopic lymphadenectomy, surgeons can
 remove and examine the lymph nodes in the abdomen. This may help to find cancer in the lymph
 nodes that cannot be detected using standard techniques. If these lymph nodes contain cancer,
 the area of the body treated with radiation can be "extended" to treat new areas. This means
 that radiation will be used to treat both the para-aortic lymph nodes (lymph nodes in the
 abdomen) in addition to the standard pelvic radiation.

 Before beginning your radiation therapy, you will be taken to the operating room for the
 laparoscopy procedure. The laparoscopy procedure involves placing a telescope-like instrument
 through a small, usually ½ inch, incision (cut) in the abdomen. Three other small incisions
 are made to place additional instruments that may be needed to complete the surgery. Before
 the laparoscope is inserted, carbon dioxide gas (CO2) is introduced into the side of the
 abdomen. This gas helps to separate the organs inside the abdominal cavity, making it easier
 for the surgeon to see. The laparoscope is then inserted through the small incision. The
 laparoscope has a small camera on the end of the instrument. This is attached to a
 high-resolution TV monitor. Using the TV monitor, the surgeon can see inside your body
 without making a large incision. While watching the TV monitor, the surgeon uses the
 laparoscope to find the para aortic lymph nodes and removes them. Once the procedure is
 finished, the carbon dioxide gas is removed and you are taken to the recovery room.

 The lymph nodes that were removed will be sent to the lab and evaluated for the presence of
 any cancer cells. If cancer is found, your radiation therapy will be adjusted to also treat
 the lymph nodes. If no signs of cancer is found, you will receive the standard radiation
 therapy.

 If, during the laparoscopy procedure, the surgeon finds an obvious sign of cancer (such as
 enlarged lymph nodes) then an exploratory laparotomy will be performed. This procedure
 involves making a long incision in the abdomen so that the surgeon can remove any additional
 lymph nodes that may contain cancer.

 All participants will undergo a Positron Emission Tomography scan, also called a PET scan,
 before their scheduled surgery. This test studies the function of organs such as the heart,
 brain, and bone. The test is different from other imaging tests such as x-rays, CT scans, or
 MRI's because PET images show how tissues function. The other imaging methods show what the
 tissues look like. The PET scanner is similar to a CT or an MRI scanner. The bed on the
 scanner moves during the exam so that each area of the body can be imaged. The PET scanner
 makes no noise.

 Before the PET scan, a blood test (about 1 teaspoon) will be done to check your blood sugar
 level. The day before the scan, you will be asked to follow a special diet. This is to
 control the amount of sugar in your bloodstream. One the day of the scan a small tube will be
 placed in your vein to administer a very small amount of radioactive material. This material
 allows the PET scanner to "see" where the sugar is metabolized in your body. The amount of
 time the scan takes depends on how tall you are and why you are having the test. After the
 scan, patients rest for about 45 to 90 minutes before being discharged. Family members are
 not allowed to come in with the patient during the test. Overall, you should allow about 3
 hours for this scan. If you had this test prior to entering the study, you do not have to
 have this test repeated as long as it was done within 4 weeks of the laparoscopy.

 This is an investigational study. The PET/CT scan will be performed only at M. D. Anderson
 and the laparoscopy procedure will be performed at both M. D. Anderson and Lyndon Baines
 Johnson General Hospital (LBJGH). The chemotherapy and/or radiation treatments may be done at
 either MD Anderson or in your hometown. Up to 70 patients will be enrolled in this
 multicenter study. Up to 55 will be enrolled at M. D. Anderson.
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 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.

 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.