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

Open (Enrolling)
Cervical Cancer

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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

- 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.

Inclusion Criteria:

1. Squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1
or 2 adenocarcinoma of cervix

2. FIGO stage IA2 or IB1 disease

3. Tumor diameter
4. No lymphovascular space invasion present on biopsy or previous cone

5. Cone margins & ECC specimen negative for invasive cancer, CIN 2, CIN3 or
adenocarcinoma-in-situ (1 repeat cone/ECC permitted)

6. Patients eligible for study if Cone and ECC was performed prior to enrollment in
study, provided the above pathologic eligibility criteria are met & cone/ECC was
performed within 12 wks of enrollment

7. Patients must sign approved ICD

8. If patient is of childbearing potential, must have a negative blood or urine
pregnancy test prior to surgery.

9. Patients who have had a simple hysterectomy (cut-through hysterectomy) prior to
enrollment are eligible, provided the above pathology criteria are met. If
lymphadenectomy was performed the lymph nodes must be negative. If lymphadenectomy
was not performed, patients will undergo this procedure as part of the study.

10. Less than 10mm of cervical stromal invasion

Exclusion Criteria:

1. Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk

2. Grade 3 adenocarcinoma

3. FIGO stage IA1, IB2, II, III or IV disease

4. Tumors >2 cm in diameter on physical exam or imaging studies (if performed)

5. Presence of LVSI

6. Cone margins or ECC specimen positive for invasive cancer, CIN2, CIN3 or
adenocarcinoma-in-situ (one repeat cone permitted)

7. Neoadjuvant radiation therapy or chemotherapy for cervical cancer

8. Patients unwilling or unable to provide informed consent for the study

9. Greater than or equal to 10mm of cervical stromal invasion

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immediate Failure Rate

Outcome Description:

The immediate failure rate is defined as residual disease in the simple hysterectomy specimen.

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

Kathleen Schmeler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Cervix
  • Stage IA2 or IB1 Carcinoma
  • Conservative Surgery
  • Cervix Cancer recurrence
  • Quality of Life Factors
  • Pelvic lymph nodes
  • Pelvic Lymphadenectomy
  • parametrium
  • Cervical cone biopsy
  • Endocervical curettage
  • ECC
  • Uterine Cervical Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
UT MD Anderson Cancer Center Houston, Texas  77030
Texas Tech University HSC Lubbock, Texas  79430
Midwest GYN Oncology Omaha, Nebraska  68114