Overview

This trial was last updated 7 days ago.
Condition cervical cancer
Treatment conservative surgery
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Start date August 2009
End date August 2018
Trial size 195 participants
Trial identifier NCT01048853, 2008-0118, NCI-2012-01254

Summary

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).

Recruiting in the following locations…

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Removal of the pelvic lymph nodes (pelvic lymphadenectomy)
conservative surgery pelvic lymphadenectomy
Removal of the pelvic lymph nodes (pelvic lymphadenectomy)

Primary Outcomes

Measure
Immediate Failure Rate
time frame: 5 Years

Secondary Outcomes

Measure
Cervix Cancer Recurrence Rate
time frame: At 2 Years

Eligibility Criteria

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 in diameter on physical exam or imaging studies 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 10. Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment 11. Patients who have had a simple hysterectomy (cut through hysterectomy)

Additional Information

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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.