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

NCT01365156 | Completed Phase 3 Results

• 2 other identifiers: 2010-0952NCI-2011-02400
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Keywords

locally advanced cervical cancer; pretherapeutic para-aortic surgical staging; radiologic staging; pretherapeutic surgical staging; para-aortic metastatic disease

Outcome Measures

Primary Outcomes (1)

• Overall Survival Rate

  To determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging followed by tailored chemoradiation when compared to patients who undergo standard radiologic staging followed by whole pelvic chemoradiation therapy.

  3 years

Study Arms (2)

EPLND + Chemoradiation

EXPERIMENTAL

Group 1: Extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy

Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND); Radiation: Chemoradiation

Chemoradiation

ACTIVE COMPARATOR

Group 2: standard-of-care chemoradiation therapy only

Radiation: Chemoradiation

Interventions

Extraperitoneal laparoscopic lymphadenectomy (EPLND) PROCEDURE

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

Also known as: Laparoscopic Extraperitoneal lymphadenectomy, Extraperitoneal Para-aortic Lymph Node Dissection, EPLND

EPLND + Chemoradiation

Chemoradiation RADIATION

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.

Chemoradiation; EPLND + Chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women with stage IA or IB1 cancer.
• Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
• Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
• Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
• Women who have undergone simple or radical hysterectomy prior to radiotherapy.
• Women with planned treatment of radiotherapy only (without chemotherapy).
• Women with planned treatment of palliative radiotherapy.
• Women with metastatic disease outside of pelvis.
• Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) \< 5 years from their new diagnosis of cervical cancer.
• Women who are pregnant, women who are likely to be pregnant or are breastfeeding.
• 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.
• (French Sites Only) Women not affiliated with Social Security System in France.
• (French Sites Only) Women deprived of liberty or under guardianship.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (3)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Vall d'Hebron Hospital

Brussels, Belgium

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Adenosquamous; Adenocarcinoma; Uterine Cervical Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Results Point of Contact

• Title: Michael Frumovitz,Professor, Gyn Onc & Reproductive Med
• Organization: UT MD Anderson Cancer Center

mfrumovitz@mdanderson.org

(713) 792-9599

Study Officials

• Michael M. Frumovitz, MD, MPH

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: August 1, 2011
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-01

Locations

US (2); BE (1)