Conservative Surgery for Women With Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01048853
First received: January 12, 2010
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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
Cervical Cancer
Procedure: Conservative Surgery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 100
Study Start Date: August 2009
Estimated Primary Completion Date: August 2016 (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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 on physical exam & imaging studies (if performed)
  4. No lymphovascular space invasion 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 5.0mm of the margin 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 approved ICD
  9. If patient is of childbearing potential, must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study.
  10. Patients who have had a simple hysterectomy (cut-through hysterectomy) prior to enrollment are eligible, provided the above pathology criteria are met. If lymphadenectomy was performed the lymph nodes must be negative. If lymphadenectomy was not performed, patients will undergo this procedure as part of the study.

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 (if performed)
  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
  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 ClinicalTrials.gov identifier: NCT01048853

Contacts
Contact: Kathleen Schmeler, MD 713-745-3518
Contact: Jacalyn B Gano, MSW, BS, AS 713-794-1422

Locations
United States, Nebraska
Midwest GYN Oncology Recruiting
Omaha, Nebraska, United States, 68114
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Texas
Texas Tech University HSC Recruiting
El Paso, Texas, United States, 79905
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Kathleen Schmeler, MD         
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Colombia
Instituto de Cancerologia-Clìnica Las Amèricas Recruiting
Bogota, Colombia
Czech Republic
JG Mendel Cancer Centre Recruiting
Novy Jicin, Czech Republic
Charles University Recruiting
Prague, Czech Republic
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Kathleen Schmeler, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01048853     History of Changes
Other Study ID Numbers: 2008-0118, NCI-2012-01254
Study First Received: January 12, 2010
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cervix
Stage IA2 or IB1 Carcinoma
Conservative Surgery
Cervix Cancer recurrence
Quality of Life Factors
Pelvic lymph nodes
Pelvic Lymphadenectomy
parametrium
Cervical cone biopsy
Endocervical curettage
ECC

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014