Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365156
Recruitment Status : Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Squamous Cell Carcinoma Adenosquamous Carcinoma Adenocarcinoma Locally Advanced Malignant Neoplasm Cervical Cancer Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND) Radiation: Chemoradiation Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
Actual Study Start Date : August 2011
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: EPLND + Chemoradiation
Group 1: Extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy
Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND)
Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment
Other Names:
  • Laparoscopic Extraperitoneal lymphadenectomy
  • Extraperitoneal Para-aortic Lymph Node Dissection

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.

Active Comparator: Chemoradiation
Group 2: standard-of-care chemoradiation therapy only
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.

Primary Outcome Measures :
  1. Three Year Overall Survival Rate [ Time Frame: 3 years ]

    Overall survival (OS) with the product limit estimator of Kaplan and Meier

    Overall survivals with pretherapeutic para-aortic surgical staging followed by tailored chemoradiation when compared to patients who undergo standard radiologic staging followed by whole pelvic chemoradiation therapy after PET scan only.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
  2. Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes.
  3. Women with planned treatment of primary definitive chemoradiation therapy.
  4. Patient information and written informed consent form signed.
  5. Age >/= 18 years old
  6. ECOG Performance Status (PS) </= 2
  7. Life Expectancy >/= 3 months

Exclusion Criteria:

  1. Women with stage IA or IB1 cancer.
  2. Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
  3. Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
  4. Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
  5. Women who have undergone simple or radical hysterectomy prior to radiotherapy.
  6. Women with planned treatment of radiotherapy only (without chemotherapy).
  7. Women with planned treatment of palliative radiotherapy.
  8. Women with metastatic disease outside of pelvis.
  9. Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) < 5 years from their new diagnosis of cervical cancer.
  10. Women who are pregnant, women who are likely to be pregnant or are breastfeeding.
  11. Women with any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent or compliance to study procedures.
  12. (French Sites Only) Women not affiliated with Social Security System in France.
  13. (French Sites Only) Women deprived of liberty or under guardianship.

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 identifier (NCT number): NCT01365156

Layout table for location information
United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Vall d'Hebron Hospital
Brussels, Belgium
Sponsors and Collaborators
M.D. Anderson Cancer Center
Layout table for investigator information
Study Chair: Michael M. Frumovitz, MD, MPH M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01365156     History of Changes
Other Study ID Numbers: 2010-0952
NCI-2011-02400 ( Registry Identifier: NCI CTRP )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by M.D. Anderson Cancer Center:
locally advanced cervical cancer
pretherapeutic para-aortic surgical staging
radiologic staging
pretherapeutic surgical staging
para-aortic metastatic disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed