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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. Identifier: NCT01048853
Recruitment Status : Unknown
Verified May 2019 by M.D. Anderson Cancer Center.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2010
Last Update Posted : May 16, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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).

Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: Conservative Surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Surgery for Women With Low-risk, Early Stage Cervical Cancer
Actual Study Start Date : August 2009
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Conservative Surgery
Removal of the pelvic lymph nodes (pelvic lymphadenectomy)
Procedure: Conservative Surgery
Removal of the pelvic lymph nodes (pelvic lymphadenectomy)
Other Name: pelvic lymphadenectomy

Primary Outcome Measures :
  1. Immediate Failure Rate [ Time Frame: 5 Years ]
    The immediate failure rate is defined as residual disease in the simple hysterectomy specimen.

Secondary Outcome Measures :
  1. 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%.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01048853

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United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Kathleen Schmeler, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01048853    
Other Study ID Numbers: 2008-0118
NCI-2012-01254 ( Registry Identifier: NCI CTRP )
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Keywords provided by M.D. Anderson Cancer Center:
Stage IA2 or IB1 Carcinoma
Conservative Surgery
Cervix Cancer recurrence
Quality of Life Factors
Pelvic lymph nodes
Pelvic Lymphadenectomy
Cervical cone biopsy
Endocervical curettage
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases