Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix
Condition: Cervical Squamous Cell Carcinoma; Adenosquamous Carcinoma; Adenocarcinoma; Locally Advanced Malignant Neoplasm; Cervical Cancer
MeSH terms: Carcinoma; Uterine Cervical Neoplasms; Neoplasms; Carcinoma, Adenosquamous
Intervention: Extraperitoneal laparoscopic lymphadenectomy (EPLND); Chemoradiation
Intervention description: Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: locally advanced cervical cancer; pretherapeutic para-aortic surgical staging; radiologic staging; pretherapeutic surgical staging; para-aortic metastatic disease

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.
    

Eligibility 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.