Conservative Surgery in Treating Patients with Low-Risk Stage IA2 or IB1 Cervical Cancer
This trial is active, not recruiting.
|Sponsor||M.D. Anderson Cancer Center|
|Start date||August 2009|
|End date||August 2018|
|Trial size||81 participants|
|Trial identifier||NCT01048853, 2008-0118, NCI-2012-01254|
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).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Removal of the pelvic lymph nodes (pelvic lymphadenectomy)
Immediate Failure Rate
time frame: 5 Years
Cervix Cancer Recurrence Rate
time frame: At 2 Years
Female participants of any age.
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. Less than 10mm of cervical stromal invasion 6. Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) CIN II, CIN III or adenocarcinoma-in-situ (A negative margin is defined as no invasive cancer within 1.0mm of both the endocervical and ectocervical margins and no AIS or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted) 7. Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met. The cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study. If the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria. 8. Patients must sign approved ICD 9. If patient is of childbearing potential, must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study. 10. 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. 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. Greater than or equal to 10mm of cervical stromal invasion 7. Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted) 8. Neoadjuvant radiation therapy or chemotherapy for cervical cancer 9. Patients unwilling or unable to provide informed consent for the study
|Official title||Conservative Surgery for Women With Low-risk, Early Stage Cervical Cancer|
|Description||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 195 patients will take part in this multicenter study. Up to 40 participants will be enrolled at MD Anderson and the Harris Health System.|
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