Trial Information

Conservative Surgery for Women With Low-risk, Early Stage Cervical Cancer

Stage IA2 or IB1 cervical cancer is currently treated by a radical hysterectomy (removal of
the uterus, cervix, and the parametrium) or radical trachelectomy (removal of the cervix and
the parametrium). The parametrium is the tissue next to the uterus and cervix that holds
these organs in place. Pelvic lymph nodes and possibly para-aortic lymph nodes (near the
aorta in the abdomen) are also removed. This procedure is called a pelvic and para-aortic
lymphadenectomy. While these surgeries are very effective, significant side effects can
occur, such as bladder, bowel, and/or sexual dysfunction.

Conservative surgery involves the removal of the pelvic lymph nodes (pelvic
lymphadenectomy). The cervix and parametrium are left intact. During surgery, for women no
longer wanting children, a simple hysterectomy (removal of the uterus with or without
removal of the fallopian tubes and ovaries) can also be performed. In this study,
participants will have conservative surgery.

Conservative Surgery:

If you are found to be eligible to take part in this study, you will have conservative
surgery. You will be taken to the operating room where you will be put to sleep using
general anesthesia. You will have your pelvic lymph nodes removed, however, the parametrium
is left intact. If you no longer want to have children, you can have a simple hysterectomy.
Participants who have had a hysterectomy will have only the pelvic lymph nodes removed.
Removal of the pelvic lymph nodes takes about 1-2 hours. If you also decide to have a simple
hysterectomy, this procedure will take about 2 hours. You will sign a separate consent for
this surgery, which will discuss the risks in more detail.

Study Procedures:

If you agree to take part in this study, the following information will be collected from
your medical record and/or you will be asked for this information when you enroll in the
study:

- Age at the time of the cancer diagnosis

- Race

- Height and weight to determine body mass index (BMI)

- Menopausal status

- Symptoms

- History of sexually transmitted diseases

- Smoking history

- Child bearing history

The following information will be collected from your medical record and/or you will be
asked for this information after surgery:

- How long the surgery took to complete

- What procedures were performed during the surgery

- How long you were in the hospital

- If there was any blood loss before or after surgery

- If blood transfusions were performed before or after surgery

- What complications, if any, happened that were related to the surgery

Starting 3 months after your first visit after surgery, you will have study visits every 3
months for 2 years. At these visits, the following tests and procedures will be performed:

- You will have a physical exam.

- You will have a pelvic exam.

- You will have a pap smear.

You will be contacted by telephone or by mail every year for 3 years. You will be asked if
the cancer has returned, when you last saw your doctor, and any complications or problems
you may be having. If you are called, the call will take less than 10 minutes.

Length of Study:

You may remain on study for 5 years after surgery. You will be taken off study early if
either the lymph nodes or cervix (if a simple hysterectomy was performed) removed during
surgery contain cancer.

This is an investigational study. Up to 100 patients will take part in this multicenter
study. Up to 30 participants will be enrolled at MD Anderson.