Prospective, Randomised and Multi-centric Therapy Optimisation Study for Examining the Influence of Surgical Staging on the Oncological Results for Patients With Cervix Carcinoma of the FIGO Stages IIB-IV After Chemoradiation
The aim of this study is to determine whether the modified therapy on the basis of operative
staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical
cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a
significant improvement of disease-free survival.
To this end, 250 patients with histologically verified cancer of the cervix uteri of the
stages IIB-IV shall be randomised to a standard arm (ARM B), whereby the therapy shall be
conducted on the basis of the clinical FIGO stage.
The patients randomised to the test arm (Arm A), after determining the clinical FIGO stage,
shall initially receive an operative staging in the form of a pelvine paraaortal
lymphadenectomy (laparoscopic or open). On the basis of the operatively obtained findings, a
("surgically") modified tumour stage shall be determined. This "surgical" tumour stage,
which shall take into account the affection of the lymph nodes, the infiltration of the
neighbouring organs and the intraperitoneal spread, shall serve as the basis for the
execution of primary, combined radio-chemotherapy. The primary end-point is the disease-free
survival of both groups, the secondary endpoints are overall survival, the local control of
both groups, as well as the determination of toxicity and the quality of life.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
DFS (disease-free survival)
Simone Marnitz, PD
Department of Radiooncology (Charité Campus Mitte und Virchow), Charitéplatz 1, 10117 Berlin, Germany
Germany: Federal Office for Radiation Protection