Trial Information

A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 study groups. You have an equal chance of being
assigned to either group.

If you are in Group 1, you will have an extraperitoneal laparoscopic lymphadenectomy
followed by chemoradiation therapy.

If you are in Group 2, you will receive standard-of-care chemoradiation therapy only.

Study Procedure and Visits:

If you are in Group 1, you will have an extraperitoneal laparoscopic lymphadenectomy, a
procedure where surgeons remove and examine the lymph nodes in the abdomen. The study
doctor will explain the risks for this procedure to you and you will sign a separate
surgical consent form. This procedure will be performed 7-10 days before chemoradiation
treatment begins.

During the laparoscopy procedure, a telescope-like instrument with a small camera on the end
(a laparoscope) will be placed through a small cut in the abdomen. Three (3) other small
cuts will be made to place instruments that may be needed to complete the surgery. Before
the laparoscope is inserted, carbon dioxide gas will be pumped into your abdomen making it
easier for the surgeon to see. The laparoscope will then be placed through the small cut.
Using a TV monitor, the surgeon will use the camera to find the lymph nodes in the abdomen
and then remove them. After the procedure is finished, the carbon dioxide gas will be
removed and you will be taken to the recovery room.

If these lymph nodes contain cancer, the area of the body treated with radiation can be
"extended" to treat new areas. Future treatment options will be based on what is found.
This means that radiation will be used to treat both the lymph nodes in the abdomen and the
standard area of radiation in the pelvis.

Participants in both groups will then have radiation for 5 days in a row for 5 to 5½ weeks.
If the study doctor thinks it is needed and you agree, you will have extra radiation
treatments.

Participants in both groups will receive cisplatin chemotherapy by vein over about 2 hours,
1 time every week for about 6 weeks. In most cases, treatment is given on Mondays (Days 1,
8, 15, 22, 29, and 36).

After 5 to 5½ weeks of chemotherapy and radiation treatment, participants in both groups
will receive implants in the pelvis for about 48 hours. You will remain in the hospital at
this time. The study doctor will explain the risks for this procedure to you and you will
sign a separate surgical consent form.

Length of Study:

You may be on study for up to 5 years. Your participation on the study will be over after
you have completed radiation treatment and the follow-up visits described below. You may be
taken off study if intolerable side effects occur or if you are unable to follow study
directions.

Long-Term Follow-Up:

The following tests and procedures will be performed:

- You will have a PET scan to check the status of the disease 3 months after you complete
radiation treatment.

- You have a CT scan to check the status of the disease every 6 months for the next 3
years after that.

You will visit the clinic for a physical exam:

- Every 3 months for the first 2 years

- Every 6 months for the next 3 years, and

- One (1) time each year after that, up to 5 years

This is an investigational study. The extraperitoneal laparoscopic lymphadenectomy is
considered investigational. Chemoradiation treatment is FDA approved for the treatment of
cervical cancer.

Up to 600 patients will take part in this multicenter study. Up to 40 will be enrolled at
MD Anderson.