INTERNATIONAL VALIDATION STUDY OF SENTINEL NODE BIOPSY IN EARLY CERVICAL CANCER - SENTICOL III

• Applicant: Professor Dr. Peter Hillemanns
• Subject Area: Gynaecology and Obstetrics ; Hematology, Oncology
• Term: since 2021
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 433637088

Cervical cancer is today the 4th most common cancer in women worldwide and the most frequent HPV related cancer. The standard therapy for early cervical carcinoma involves surgical removal of the uterus and surrounding tissues (radical hysterectomy) as well as the resection of pelvic lymph nodes (radical pelvic lymph node dissection). However, radical lymph node dissection is associated with a significant reduction in quality of life due to frequent complications such as swelling of the skin and subcutaneous tissues due to lymph accumulation (lymphedema), nerve disorders and the accumulation of lymph fluid in endothelium-free spaces (lymphocytes). The sentinel lymph node dissection, in contrast, represents an alternative through the targeted removal of the lymph nodes with the highest risk of metastasis. It also permits a significantly increased detection rate of micrometastases through histological ultrastaging. To date, only retrospective but no reliable prospective data is available to confirm the oncological safety of sentinel lymph node dissection alone compared to radical pelvic lymph node dissection. These observations are essential to make clear recommendations for this procedure. This prospective, multicenter, single randomized study is designed to evaluate the non-inferiority in disease-free survival and the improved quality of life after sentinel lymph node dissection versus radical pelvic lymph node dissection. A two-arm design is employed for this purpose, in which radical hysterectomy/trachelectomy with sentinel lymph node dissection is compared to radical hysterectomy/trachelectomy with radical lymph node dissection. Inclusion of patients is carried out according to the indication of national guidelines. A total of 200 patients will be included in 21 participating German centres as part of the international SENTICOL III study (GINECO).

• DFG Programme: Clinical Trials
• Co-Investigator: Privatdozent Dr. Rüdiger Klapdor