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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01048853 |
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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Conservative Surgery |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathleen Schmeler, MD | 713-745-3518 | |
| Contact: Jacalyn B Gano, MSW, BS, AS | 713-794-1422 |
| 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 | |
| Study Chair: | Kathleen Schmeler, MD | UT MD Anderson Cancer Center |
More Information
| 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: | April 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |