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1. To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features
1. To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features
2. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy
3. To estimate the sensitivity of sentinel lymph node biopsy in the determination of pelvic lymph node metastases in this group of patients
4. To compare the treatment-associated morbidity in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy
5. To assess quality of life factors, sexual functioning, symptoms and satisfaction with healthcare decisions in this group of patients
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.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
You will have a cervical cone biopsy and endocervical curettage (ECC) performed. A cone biopsy is surgery to remove a cone-shaped piece of tissue from the cervix and cervical canal. It is used to diagnose cervical cancer and also to learn how extensive the disease is. An ECC is a procedure using a curette, a spoon-shaped instrument, that is used to scrape the mucus membrane of the endocervical canal (passageway between cervix and uterus) in order to get a tissue sample.
The tissue taken from both of these procedures will be reviewed by a pathologist from M. D. Anderson.
If your tissue samples are negative for invasive cancer or adenocarcinoma-in-situ (AIS), you will be eligible for conservative surgery.
If your tissue samples are positive for invasive cancer and/or AIS, you may have the cervical bone biopsy and ECC repeated. If the tissue samples are negative after the second procedure, you will be eligible for conservative surgery. If your tissue samples from the second procedure are positive, you will be removed from study and other treatment options will be offered.
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. 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.
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
- Height and weight to determine body mass index (BMI)
- Menopausal status
- 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
You will have study visits every 3 months for 2 years after surgery. 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 10 participants will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Midwest GYN Oncology
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-07-23T21:11:08-0400
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