Conservative Surgery for Women With Cervical Cancer

This study is currently recruiting participants.
Verified January 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: January 6, 2014
Last verified: January 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 ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Primary Completion Date: August 2015 (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. Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, CIN 2, CIN 3 or adenocarcinoma-in-situ (one repeat cone and ECC permitted)
  6. Patients eligible for the study if the cone and ECC were performed prior to pre-enrollment in the study, provided the above pathologic eligibility criteria are met and the cone and ECC were performed within 12 weeks prior to pre-enrollment in the study
  7. Patients must sign approved ICD
  8. If patient is of childbearing potential, must have a negative blood or urine pregnancy test prior to surgery.
  9. 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.
  10. Less than 10mm of cervical stromal invasion

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. Cone margins or ECC specimen positive for invasive cancer, CIN2, CIN3 or adenocarcinoma-in-situ (one repeat cone permitted)
  7. Neoadjuvant radiation therapy or chemotherapy for cervical cancer
  8. Patients unwilling or unable to provide informed consent for the study
  9. Greater than or equal to 10mm of cervical stromal invasion
  Contacts and Locations
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 Not yet recruiting
Omaha, Nebraska, United States, 68114
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
United States, Texas
Texas Tech University HSC Not yet recruiting
El Paso, Texas, United States, 79905
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Kathleen Schmeler, MD         
Colombia
Instituto de Cancerologia-Clìnica Las Amèricas Recruiting
Bogota, Colombia
Czech Republic
JG Mendel Cancer Centre Not yet recruiting
Novy Jicin, Czech Republic
Charles University Not yet 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
Study First Received: January 12, 2010
Last Updated: January 6, 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 April 14, 2014