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Conservative Surgery for Women With Cervical Cancer
This study is currently recruiting participants.
Verified January 2017 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01048853
First received: January 12, 2010
Last updated: January 4, 2017
Last verified: January 2017
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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 | Phase |
|---|---|---|
| Cervical Cancer | Procedure: Conservative Surgery | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 ]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 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | August 2018 (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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix
- FIGO stage IA2 or IB1 disease
- Tumor diameter </= 2 cm on physical exam & imaging studies (if performed)
- No lymphovascular space invasion present on biopsy or previous cone
- Less than 10mm of cervical stromal invasion
- 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)
- 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.
- Patients must sign approved ICD
- If patient is of childbearing potential, must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study.
- 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:
- Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies
- Grade 3 adenocarcinoma
- FIGO stage IA1, IB2, II, III or IV disease
- Tumors >2 cm in diameter on physical exam or imaging studies
- Presence of LVSI
- Greater than or equal to 10mm of cervical stromal invasion
- Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted)
- Neoadjuvant radiation therapy or chemotherapy for cervical cancer
- Patients unwilling or unable to provide informed consent for the study
- Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment
- 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 ClinicalTrials.gov identifier: NCT01048853
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048853
Contacts
| Contact: Kathleen Schmeler, MD | 713-745-3518 |
Locations
| 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
Investigators
| Study Chair: | Kathleen Schmeler, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov 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: | January 4, 2017 |
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 July 14, 2017