A Phase III Randomized Study of Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Overall Survival Comparison Between the 2 Arms
- Sponsor
- Muriel POUBLANC
- Primary Endpoint
- Overall survival
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Muriel POUBLANC
Dr Alejandra MARTINEZ
Institut Claudius Regaud
Eligibility Criteria
Inclusion Criteria
- •Women with clinical stage from 1B2 to 4A cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
- •Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes (see addendum below) 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.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤
- •Life expectancy ≥ 3 months.
Exclusion Criteria
- •Women with stage 1A or 1B1 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 PET positive high common / paraaortic lymph node metastasis confirmed by biopsy (see addendum below).
- •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.
Outcomes
Primary Outcomes
Overall survival
Time Frame: 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.