Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix

NCT01365156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-02-03

Study results available
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Summary

The goal of this clinical research study is to learn if a surgical procedure called an extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation therapy can help to control the disease for a longer time than standard-of-care chemotherapy and whole pelvic radiation therapy.

Conditions

  • Cervical Squamous Cell Carcinoma
  • Adenosquamous Carcinoma
  • Adenocarcinoma
  • Locally Advanced Malignant Neoplasm
  • Cervical Cancer

Interventions

PROCEDURE

Extraperitoneal laparoscopic lymphadenectomy (EPLND)

Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment

RADIATION

Chemoradiation

Radiation for 5 days in a row for 5 to 5½ weeks plus Cisplatin Chemotherapy cisplatin chemotherapy by vein over about 2 hours, 1 time every week for about 6 weeks.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael M. Frumovitz, MD, MPH · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2020-01-24
Completion
2020-01-24

Countries

  • United States
  • Belgium

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01365156 on ClinicalTrials.gov