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Conservative Surgery for Women With Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01048853
Recruitment Status : Active, not recruiting
First Posted : January 14, 2010
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE January 12, 2010
First Posted Date  ICMJE January 14, 2010
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE August 2009
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2013)
Immediate Failure Rate [ Time Frame: 5 Years ]
The immediate failure rate is defined as residual disease in the simple hysterectomy specimen.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
Immediate Failure Rate [ Time Frame: 5 Years ]
Change History Complete list of historical versions of study NCT01048853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
Cervix Cancer Recurrence Rate [ Time Frame: At 2 Years ]
Recurrence rate estimated at 2 years with an exact 95% binomial confidence interval. If study completed with 100 patients and only 1 patient with recurrence by 2 years following completion of therapy, estimate of the recurrence rate at 2 years will be 0.05% to 4.92%.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
Cervix Cancer Recurrence Rate [ Time Frame: At 2 Years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Surgery for Women With Cervical Cancer
Official Title  ICMJE Conservative Surgery for Women With Low-risk, Early Stage Cervical Cancer
Brief 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).
Detailed 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) and/or lymphatic mapping with sentinel lymph node biopsy. 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 MDAnderson.

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 cone 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 by pelvic lymph node dissection and/or lymphatic mapping with sentinel lymph node biopsy, 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/procedure, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE Procedure: Conservative Surgery
Removal of the pelvic lymph nodes (pelvic lymphadenectomy)
Other Name: pelvic lymphadenectomy
Study Arms  ICMJE Experimental: Conservative Surgery
Removal of the pelvic lymph nodes (pelvic lymphadenectomy)
Intervention: Procedure: Conservative Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2016)
195
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2010)
100
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed squamous cell carcinoma of the cervix (any grade) or Histologically confirmed grade 1 or 2 adenocarcinoma of the cervix
  2. FIGO stage IA2 or IB1 disease
  3. Tumor diameter </= 2 cm on physical exam and on imaging studies
  4. No lymphovascular space invasion (LVSI) 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 an approved informed consent document
  9. If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study.
  10. Imaging with Positron emission tomography (PET) scan, computed tomography (CT) scan of the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment.

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
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Colombia,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01048853
Other Study ID Numbers  ICMJE 2008-0118
NCI-2012-01254 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kathleen Schmeler, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP