Ovarian Cancer 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]

This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations

Eligibility Criteria:

  • Women 35-50 years of age, inclusive
  • Patients who have declined or elected to defer RRSO after proper counselling to  clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with  delayed oophorectomy arms) or patients who are undergoing RRSO (for the  RRSO arm)
  • At least one intact ovary and fallopian tube; and premenopausal
  • Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required.
  • Exclusion: Women with a history of any prior cancer who have received chemotherapy within the  past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or  pelvis at any prior time

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut

Cancer Clinical Research Office