Trial Information

A Pilot Study of Laparoscopic Extraperitoneal Lymph Node Dissection in Patients With Locally Advanced Cervical Cancer

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.