Overall Survival Comparison Between the 2 Arms Clinical Trial
Official title:
A Phase III Randomized Study of Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
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.
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. ;