Advertisement

Topics

Conservative Surgery for Women With Cervical Cancer

2014-07-23 21:11:08 | BioPortfolio

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).

Primary Objective

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

Secondary Objectives

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

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.

Screening Tests:

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.

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

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.

Study Design

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

Conditions

Cervical Cancer

Intervention

Conservative Surgery

Location

Midwest GYN Oncology
Omaha
Nebraska
United States
68114

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:08-0400

Clinical Trials [2344 Associated Clinical Trials listed on BioPortfolio]

A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease

This study will be a non-randomized trial consisting of patients with single level (C3 to C7) symptomatic cervical disc disease who have not previously received fusion surgery at the same ...

Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain

The primary objective of the study is to investigate the efficacy of device with far-infrared (FIR) irradiation in these patients with acute cervical radiculopathy.

Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more effect...

p16 and Ki-67 Stainings and Natural Killer (NK) Cells in CIN-II Management

The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and ki-6...

Cervical Radiculopathy Trial

The primary aim of the present project is to compare the effectiveness of surgery and nonsurgical treatment in patients with cervical radiculopathy caused by either disc herniation or spon...

PubMed Articles [23382 Associated PubMed Articles listed on BioPortfolio]

A Population-Based Assessment of Urologic Procedures and Operations After Surgery or Pelvic Radiation for Cervical Cancer.

The treatment of cervical cancer can result in genitourinary morbidity. We measured selected urologic procedures after the treatment of cervical cancer with either surgery or radiation.

The Selection of Time Interval Between Surgery and Adjuvant Therapy in Early Stage Cervical Cancer.

The optimal interval between surgery and adjuvant treatment has not yet been found in cervical cancer. And whether patients with different FIGO stage should choose different interval is unknown. The p...

Radical Surgery in Advanced Cervical Cancer Patients Receiving Bevacizumab-Containing Chemotherapy: A "Real Life Experience".

Platinum-based chemotherapy plus bevacizumab is the new standard of care in stage IVB cervical cancer (CC) patients. In this new scenario, radical surgery could be offered in selected cases with an op...

Patterns of Care for Stage IA Cervical Cancer: Use of Definitive Radiation Therapy Versus Hysterectomy.

The standard of care for clinical IA cervical cancer is surgery, but nonoperative cases may receive definitive radiation therapy (RT). Herein, we investigated national practice patterns associated wit...

Perceptions and beliefs of lay people from northern Uganda regarding surgery for diagnosis and treatment of cervical cancer.

To explore perceptions and beliefs of people in a rural community in northern Uganda regarding surgical operations for the diagnosis and treatment of cervical cancer. The aim of the study was to infor...

Medical and Biotech [MESH] Definitions

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

That portion of the stomach remaining after gastric surgery, usually gastrectomy or gastroenterostomy for cancer of the stomach or peptic ulcer. It is a common site of cancer referred to as stump cancer or carcinoma of the gastric stump.

Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

More From BioPortfolio on "Conservative Surgery for Women With Cervical Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...


Searches Linking to this Trial