NCT00500435

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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

7.6 years

First QC Date

July 10, 2007

Last Update Submit

March 22, 2012

Conditions

Cervical Cancer

Keywords

Cervical CancerLaparoscopyLymph Node DissectionExtraperitoneal Laparoscopic Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • Complication Rates

    Complication rates determined as number of participants with inherent complications to procedure calculated separately from overall complications divided by to total number of participants.

    6 Years

Study Arms (1)

Laparoscopy Procedure

Laparoscopy procedure in abdomen to remove para aortic lymph nodes of patients diagnosed with cervical cancer.

Procedure: Extraperitoneal Laparoscopic Lymphadenectomy

Interventions

Extraperitoneal Laparoscopic LymphadenectomyPROCEDURE

Laparoscope used to find and remove para aortic lymph nodes in abdomen.

Laparoscopy Procedure

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with stage IB2-IVA cervical cancer.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77030, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Pedro Ramirez, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

October 1, 2003

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

US(2)