Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00500435
First received: July 10, 2007
Last updated: March 22, 2012
Last verified: March 2012
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Purpose
Primary Objectives:
- To determine the feasibility of performing an extraperitoneal laparoscopic lymphadenectomy in patients with stage IB2-IVA cervical carcinoma who are dispositioned to undergo radiotherapy and concurrent chemotherapy.
- To document intraoperative and postoperative complications in patients undergoing extraperitoneal laparoscopic lymphadenectomy.
- To determine the rate of lymph node metastases in the para-aortic region in patients with stage IB2-IVA cervical cancer.
- To correlate histopathological findings in the para-aortic lymph nodes with preoperative imaging studies (Positron emission tomography (PET) and magnetic resonance imaging (MRI) and computed tomography (CT)).
| Condition | Intervention |
|---|---|
|
Cervical Cancer |
Procedure: Extraperitoneal Laparoscopic Lymphadenectomy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Pilot Study of Laparoscopic Extraperitoneal Lymph Node Dissection in Patients With Locally Advanced Cervical Cancer |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Complication Rates [ Time Frame: 6 Years ] [ Designated as safety issue: No ]Complication rates determined as number of participants with inherent complications to procedure calculated separately from overall complications divided by to total number of participants.
| Enrollment: | 65 |
| Study Start Date: | October 2003 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Laparoscopy Procedure
Laparoscopy procedure in abdomen to remove para aortic lymph nodes of patients diagnosed with cervical cancer.
|
Procedure: Extraperitoneal Laparoscopic Lymphadenectomy
Laparoscope used to find and remove para aortic lymph nodes in abdomen.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed with stage IB2-IVA cervical cancer.
Criteria
Inclusion Criteria:
- Patients with stage IB2-IVA cervical cancer who are candidates for treatment with radiotherapy and concurrent chemotherapy.
- Patients with biopsy-proven cervical carcinoma, any histology.
- Patients must have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on the preoperative computed tomography (CT) or magnetic resonance imaging (MRI) scan of the abdomen and pelvis.
- Patients must sign an IRB approved informed consent.
- Patients with adequate bone marrow, renal and hepatic function: White Blood Count (WBC) >/= 3,000 cells/mcl, Platelets >/= 100,000/mcl, Creatinine </= 2.0 mg%, Bilirubin </= 1.5 x the upper limit of normal and Serum glutamic pyruvic transaminase (SGPT) </= 3 x the upper limit of normal.
- Zubrod Performance Status of 0, 1, or 2.
- Patients must be suitable candidates for surgery.
- Patients who had a PET/CT scan prior to study entry are eligible if a) the study was done within 4 weeks of surgery, and b) they have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on either a preoperative CT or MRI scan of the abdomen and pelvis.
Exclusion Criteria:
- Patients who have had prior retroperitoneal surgery.
- Patients who have received prior pelvic or abdominal radiotherapy.
- Patients known to have upper abdominal intraperitoneal disease or evidence of ovarian metastases.
- Patients who are pregnant.
- Patients with evidence of distant metastases on chest x-ray, CT or MRI scan or by physical examination.
- Patients with contraindications to laparoscopy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500435
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Lyndon Baines Johnson General Hospital | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Pedro Ramirez, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00500435 History of Changes |
| Other Study ID Numbers: | ID03-0098 |
| Study First Received: | July 10, 2007 |
| Last Updated: | March 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Cervical Cancer Laparoscopy Lymph Node Dissection Extraperitoneal Laparoscopic Lymphadenectomy |
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 16, 2013