February 17 2020
*Not yet recruiting*
Anticipated first patient enrollment in April 2020
NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
The trial builds on clinical and translational research that suggests most ovarian cancers begin in the distal fallopian tube. This is a non-randomized trial where BRCA1 carriers will self-select their preferred surgical intervention. Risk-reducing salpingo-oophorectomy (BSO) is the established standard of care and is recommended to all BRCA1 carriers by the age of 40 or when childbearing is complete, whichever is later. This trial will determine if bilateral salpingectomy is non-inferior to BSO to reduce the risk of ovarian cancer. BRCA1 carriers between the ages of 35 and 50 will be recruited over a ten-year period and followed for a total of 16 years. It is anticipated that 2,262 BRCA1 carriers will enroll onto this study. If accrual proceeds faster than expected, the trial will be able to reach the endpoint sooner. The primary outcome measure is time to develop incident high-grade serous carcinoma (HGSC). Secondary outcomes include health-related quality of life, estrogen deprivation symptoms, sexual dysfunction, menopausal symptoms, cancer distress, and medical decision making as well as incidence of adverse events.
“This study has the potential to change our approach to ovarian cancer prevention, improve the quality of life for BRCA1 carriers, and develop the foundation for broader prevention in the general population,” stated Douglas A Levine, MD, of NYU Langone Health Perlmutter Cancer Center and Principal Investigator of the NRG-CC008 trial.
NRG Oncology looks forward to institutions opening and enrolling to the study.
More information:
ClinicalTrials.gov: NCT04251052
NRG-CC008 protocol documents will be available on CTSU when the trial opens.