Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Versus Definitive Chemoradiotherapy

Phase 3

Withdrawn

• Conditions: Overall Survival Comparison Between the 2 Arms

• Registration Number: NCT02848716
• Lead Sponsor: Muriel POUBLANC

Brief Summary

This is an international, prospective, multicenter and randomized phase III study designed to determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging when compared to radiologic staging.

Detailed Description

All eligible patients will be equally randomized between the 2 following treatment groups:

* Standard of care arm: standard chemoradiation (whole pelvis chemoradiation therapy).

* Experimental arm: pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach using either traditional laparoscopy or robotically-assisted laparoscopy.

The surgery (extraperitoneal or transperitoneal laparoscopic lymphadenectomy) is considered investigational.

Chemoradiation treatment (with either pelvis or tailored radiation) is considered as standard treatment approved in France for the treatment of cervical cancer.

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Study Start: 2016-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-17
• Primary Completion: 2021-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Women with clinical stage from 1B2 to 4A cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
2. Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes (see addendum below) 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. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
7. Life expectancy ≥ 3 months.

Exclusion Criteria

1. Women with stage 1A or 1B1 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 PET positive high common / paraaortic lymph node metastasis confirmed by biopsy (see addendum below).
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. Women not affiliated with Social Security System in France.
13. Women deprived of liberty or under guardianship.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 10 years	A Positon Emission Tomography (PET) scan will be obtained at 3 months after completion of chemoradiation therapy. CT scans will be obtained every 6 months for the next three years thereafter. Follow-up surveillance of patients will consist of serial clinical examinations by an oncologist every 3 months for the first 2 years, every 6 months for the next 3 years; then, patients will be followed annually only for collection of their survival data. Patients will come off study at 5 years after completion of initial chemoradiation therapy or at time of death.