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Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00500435
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Cervical Cancer Procedure: Extraperitoneal Laparoscopic Lymphadenectomy

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 65 participants
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
Study Start Date : October 2003
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Complication Rates [ Time Frame: 6 Years ]
    Complication rates determined as number of participants with inherent complications to procedure calculated separately from overall complications divided by to total number of participants.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500435     History of Changes
Other Study ID Numbers: ID03-0098
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012

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