Study Protocol of the LAUNCH 3 Trial: Comparing Laparoscopic and Abdominal Radical Hysterectomy for Cervical Cancer
Background
Cervical cancer remains a significant health issue in China, particularly among younger patients. The LAUNCH 3 trial seeks to evaluate the survival outcomes of patients undergoing LRH compared to ARH for stages IB3 and IIA2 cervical cancer, under stringent surgical standards.
Methods/Design
This investigator-initiated trial will randomize patients to either LRH or ARH groups. The primary endpoint is the 5-year overall survival rate, with secondary endpoints including progression-free survival, recurrence rates, and quality of life measurements. The trial adheres to the SPIRIT statement for clinical trial protocols and includes a trial steering committee for oversight.
Discussion
The study aims to provide evidence-based information on the choice of surgical method for cervical cancer treatment, focusing on the survival benefits and quality of life post-surgery. The trial's findings could influence clinical practice by offering insights into the efficacy of minimally invasive versus open surgical approaches for cervical cancer.
Trial Registration
The trial is registered on ClinicalTrials.gov (NCT04939831) and was approved by the Institutional Review Board of the Obstetrics and Gynecology Hospital of Fudan University. Recruitment began in May 2021 and is expected to conclude by May 2024, with the final follow-up scheduled for May 2029.
Conclusion
The LAUNCH 3 trial represents a significant step forward in understanding the best surgical approaches for treating cervical cancer, with the potential to improve patient outcomes and quality of life. The study's rigorous design and comprehensive follow-up plan underscore its importance in the ongoing effort to combat cervical cancer effectively.