August 07 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 recently opened NRG-CC008 trial, also known as the SOROCk trial, will be comparing bilateral salpingectomy with delayed oophorectomy to bilateral salpingo-oophorectomy to see if the removal of the fallopian tubes followed by the removal of the ovaries at a later time can help reduce the risk of ovarian cancer among premenopausal women with inherited BRCA1 mutations. The current standard of care is to remove both the ovaries and fallopian tubes, which has been shown to dramatically decrease the risk of ovarian cancer and death in women with mutations; however, the removal of only the fallopian tubes may also help lessen the risk of ovarian cancer without needing to remove the ovaries. The trial will also survey patients on their quality of life before, during, and following treatment.
The SOROCk trial was designed to determine if women can receive the same benefit of decreased ovarian cancer risk without having to remove the ovaries, thus potentially improving quality of life. Secondary outcome measures are to assess estrogen deprivation symptoms, determine the impact on sexual function, and to assess cancer distress, medical decision making, and any adverse events from treatment. The study aims to accrue approximately 2,262 patients over 10 years.
“Since ovarian cancer typically presents at an advanced stage and it thought to originate most commonly in the fallopian tubes, it’s crucial to determine if removal of the fallopian tubes prior to removal of the ovaries can reduce the risk of ovarian cancer for women with BRCA1 mutations. The SOROCk trial will be important in determining if physicians can provide this type of alternative treatment that spares the ovaries and improves quality of life for this patient population,” stated Douglas A. Levine, MD, of the Perlmutter Cancer Center at NYU Langone Health and the Study Chair of the SOROCk trial.
Learn more about this trial on ClinicalTrials.gov
Access the protocol documents and materials on CTSU.org