February 11 2021
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. Preliminary data from the SU2C WISP trial has shown that leaving ovaries in place but removing the tubes helps younger, high-risk (BRCA mutation) women retain hormonal function however, the trial was not designed to determine whether or not removing just the tubes – instead of both tubes and ovaries – prevents ovarian cancer. What is needed is a decisive clinical trial. Along these lines, NRG-CC008/SOROCk is a newly activated international clinical trial, designed to convert this preliminary data into clinical action. The new study is ten times larger than WISP and meant to define the role of tube versus ovary removal on cancer incidence. It is a non-randomized trial where BRCA1 carriers will self-select their preferred surgical intervention. This trial will determine if bilateral salpingectomy is non-inferior to BSO to reduce the risk of ovarian cancer.
“Preliminary studies have suggested that ovarian cancer starts in fallopian tubes instead of ovaries, but that doesn’t not mean that removing the tubes alone will prevent ovarian cancer,” says Douglas A Levine, MD, of NYU Langone Health Perlmutter Cancer Center and Principal Investigator of the NRG-CC008 trial. Cancer cells that originate in the fallopian tubes might get deposited in the ovaries already, making their removal less effective for cancer prevention. NRG Oncology looks forward to many institutions opening and enrolling to the study. As of this writing, 134 sites have activated the study and 295 are pending.
More information:
ClinicalTrials.gov: NCT04251052 or www.sorock.org
NRG-CC008 protocol documents are available on CTSU.