Conservative Surgery for Women With Cervical Cancer
This study is currently recruiting participants.
Verified January 2013 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 9, 2013
Last verified: January 2013
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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 |
|---|---|
|
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 2014 (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:
- 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
- Cone margins & ECC specimen negative for invasive cancer, CIN 2, CIN3 or adenocarcinoma-in-situ (1 repeat cone/ECC permitted)
- Patients eligible for study if Cone and ECC was performed prior to enrollment in study, provided the above pathologic eligibility criteria are met & cone/ECC was performed within 12 wks of enrollment
- Patients must sign approved ICD
- If patient is of childbearing potential, must have a negative blood or urine pregnancy test prior to surgery.
- 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.
- Less than 10mm of cervical stromal invasion
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 (if performed)
- Presence of LVSI
- Cone margins or ECC specimen positive for invasive cancer, CIN2, CIN3 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
- 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 9, 2013 |
| 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 May 23, 2013