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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01365156
First received: June 1, 2011
Last updated: December 31, 2014
Last verified: December 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Three Year Overall Survival Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 600
Study Start Date: August 2011
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPLND + Chemoraditation
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
  • EPLND
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01365156

Contacts
Contact: Michael M. Frumovitz, MD, MPH 713-792-9599

Locations
United States, Texas
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Michael M. Frumovitz, MD, MPH         
Belgium
Vall d'Hebron Hospital Recruiting
Brussels, Belgium
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michael M. Frumovitz, MD, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01365156     History of Changes
Other Study ID Numbers: 2010-0952, NCI-2011-02400
Study First Received: June 1, 2011
Last Updated: December 31, 2014
Health Authority: United States: Institutional Review Board

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:
Carcinoma
Carcinoma, Adenosquamous
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on March 03, 2015