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

Completed · Phase 3

Conditions studied: Cervical Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma, Locally Advanced Malignant Neoplasm, Cervical Cancer

In brief

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.

Key facts

Study ID

NCT01365156

Run by

M.D. Anderson Cancer Center

People needed

28

Starts

2011-08-01

Expected to finish

2020-01-24

Last updated by the study team

2021-02-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Lyndon B. Johnson General Hospital — Houston, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Vall d'Hebron Hospital — Brussels, Belgium

Full record on ClinicalTrials.gov

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