The Gynecologic Oncology Group (GOG) is a multidisciplinary, multimodality cooperative clinical trial organization composed of 50 full member and 150 affiliate member university or large community hospitals in North America with designated programs in the design and conduct of new anti-cancer therapies for women with pelvic malignancies. This application describes a comprehensive program intended to orient and to evaluate gynecologic oncologists in performing standardized laparoscopic FIGO staging for endometrial cancer. Following this quality assurance study of surgical proficiency, a randomized clinical trial is described which will test effectively the benefits and risks of laparoscopic FIGO staging with laparoscopic-assisted vaginal hysterectomy and bilateral salpingo- oophorectomy (BSO) versus open FIGO staging with abdominal hysterectomy and BSO. The latter is considered the standard of practice in gynecologic oncology at the present time. The laparoscopic regimen offers potential for reduced morbidity, decreased duration of hospitalization, and improved quality of life measures. FACT, an important new quality of life instrument, and supplementary measures of physical functioning and symptom inventory will be evaluated in this study. Approximately 1200 patients will be entered in order to develop the necessary information regarding minimal access surgery in endometrial cancer. The GOG is the only clinical trial group capable of performing this definitive investigation which will demonstrate the ability to perform quality surgery in a standardized fashion throughout the heterogeneous environments comprising modern anti-cancer management.
| Walker, Joan L; Piedmonte, Marion R; Spirtos, Nick M et al. (2012) Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol 30:695-700 |
