Conservative Surgery for Women With Cervical Cancer

Official Title: “Conservative Surgery for Women With Low-risk, Early Stage Cervical Cancer”

The goal of this surgical research study is to learn if "conservative surgery" is a safe and feasible option for women with low-risk cervical cancer (stage IA2 or IB1, Grade 1 or 2).

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.

Intervention(s) in this Clinical Trial

• Procedure: Conservative Surgery
  • Removal of the pelvic lymph nodes (pelvic lymphadenectomy)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Conservative Surgery

Primary Measures

• Immediate Failure Rate
  • Time Frame: 5 Years
    Safety Issue?: No

Secondary Measures

• Cervix Cancer Recurrence Rate
  • Time Frame: At 2 Years
    Safety Issue?: No

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 </= 2 cm on physical exam & imaging studies (if performed)
• 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 histologies
• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: M.D. Anderson Cancer Center Other

Overall Clinical Trial Officials and Contacts

Kathleen Schmeler, MD Study Chair UT MD Anderson Cancer Center  

Overall Contact: Kathleen Schmeler, MD 713-745-3518 

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01048853

Study ID Number: 2008-0118

ClinicalTrials.gov Identifier: NCT01048853

Health Authority: United States: Institutional Review Board

UT MD Anderson Cancer Center website