Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer

This study has been completed.
Sponsor:
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
  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
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: NCT00500435

Locations
United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77030
UT MD Anderson Cancer Center
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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014