This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Conservative Surgery for Women With Cervical Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: January 12, 2010
Last updated: August 21, 2017
Last verified: August 2017
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 Intervention Phase
Cervical Cancer Procedure: Conservative Surgery Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

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

Secondary Outcome Measures:
  • 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%.

Estimated Enrollment: 195
Actual Study Start Date: August 2009
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01048853

Contact: Kathleen Schmeler, MD 713-745-3518

United States, Texas
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Kathleen Schmeler, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Kathleen Schmeler, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01048853     History of Changes
Other Study ID Numbers: 2008-0118
NCI-2012-01254 ( Registry Identifier: NCI CTRP )
Study First Received: January 12, 2010
Last Updated: August 21, 2017

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:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female processed this record on September 19, 2017