February 12 2024
The NRG-CC008/SOROCk 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 SU2C WISP trial was not designed to determine whether or not removing just the tubes – instead of both tubes and ovaries – prevents ovarian cancer. The SOROCk trial is an international clinical trial, designed to convert this preliminary data into clinical action.
Interview with Warner Huh, MD, Chair of the Department of Obstetrics and Gynecology at the University of Alabama Birmingham Medicine and Principal Investigator of NRG-CC008 / SOROCk.
Q: Can you provide an overview of the study?
A: Studies of ovarian cancer screening in the general population have not demonstrated a reduction in ovarian cancer mortality. High-grade pelvic serous carcinomas (HGSCs) have traditionally been thought to originate from the ovarian surface epithelium. However, more recent data strongly suggests that most HGSCs originate from precursor lesions found in the distal fallopian tube. Serous tubal intra-epithelial carcinoma (STIC) lesions are found in association with HGSCs in 50-60% of cases and other early serous precursor lesions can be identified in an additional 25% of cases. The Society of Gynecologic Oncology has recently issued recommendations that salpingectomy can be considered at the completion of childbearing in individuals at increased genetic risk of ovarian cancer who do not agree to salpingo-oophorectomy. They also indicated that approximately 30% of BRCA1 mutation carriers choose not to remove their ovaries, and the mean age at RRSO for those who do is in the late 40s, much later than recommended age per guidelines. The purpose of this study is to compare risk-reducing approaches in high-risk women with deleterious germline BRCA1 mutations; specifically, to demonstrate the non-inferiority of bilateral salpingectomy compared to bilateral salpingo-oophorectomy to reduce the incidence of ovarian cancer among deleterious germline BRCA1 mutation carriers.
Q: What are the aims of this study?
A: The primary aim is to compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations. Secondary aims of the trial include: to prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACT-ES subscale compared to women in the BSO arm, to determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients, to assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice, and to assess adverse events, graded using CTCAE v5.0.
Q: What are the most common questions you receive about this study?
A:
1) Can individuals with a BRCA2 mutation go on this trial? The answer to this is no, unfortunately.
2) Can individuals under the age of 35 go on this trial? The answer to this is no, unfortunately.
3) Can individuals who have a prior history of cancer and/or are on hormonal therapy go on this trial? Yes they can, however, they need to have completed their treatments at least 30 days prior to enrollment.
Q: Is there anything else researchers should know about this study?
A: With the last amendment, the trial allows for community gynecologists and pathologists to do the risk-reduction surgery.