Surgical Procedures for Reducing Ovarian Cancer Risk (SOROCk Trial)
Palo Alto (17 mi)Overseen byDouglas A Levine
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: NRG Oncology
No Placebo Group
Trial Summary
What is the purpose of this trial?This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals 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.
Is Bilateral Salpingectomy a promising treatment for reducing ovarian cancer risk?Yes, Bilateral Salpingectomy is a promising treatment for reducing ovarian cancer risk. It is often recommended during other surgeries like hysterectomy or sterilization to lower the chances of developing ovarian cancer. This approach is supported by medical organizations and is practiced by both specialists and general gynecologists.26789
What safety data exists for surgical procedures to reduce ovarian cancer risk?The safety data for surgical procedures to reduce ovarian cancer risk includes studies on various methods such as bilateral salpingectomy, opportunistic salpingectomy, and bilateral salpingo-oophorectomy. A pilot study on bilateral salpingectomy with delayed oophorectomy in BRCA mutation carriers suggests it is safe and acceptable. Bilateral salpingo-oophorectomy is effective in reducing ovarian cancer risk but may lead to ovarian hormone deficiency. There is also concern about primary peritoneal carcinomatosis developing after the procedure. The impact of bilateral salpingectomy on ovarian reserve is still unclear.13468
What data supports the idea that Surgical Procedures for Reducing Ovarian Cancer Risk is an effective treatment?The available research shows that risk-reducing bilateral salpingo-oophorectomy (RRBSO) is effective in reducing ovarian cancer deaths in high-risk women. It is particularly beneficial for those with hereditary gene mutations linked to breast and ovarian cancer, as it reduces mortality from high-grade serous carcinoma. However, the uptake of this procedure is not as high as expected, and more information is needed to understand the barriers. While bilateral salpingectomy alone has not been proven to lower ovarian cancer risk in BRCA mutation carriers, a pilot study is exploring its safety and acceptability when combined with delayed oophorectomy.34589
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have received cytotoxic chemotherapy within the past 30 days, you are not eligible. Endocrine therapy, maintenance ERBB2/HER2 targeted therapy, maintenance immune checkpoint inhibitor therapy, and maintenance therapy with PARP inhibitors are allowed.
Eligibility Criteria
This trial is for women aged 35-50 with a BRCA1 mutation, who are considering or have deferred risk-reducing surgery of the fallopian tubes and ovaries. They must be medically fit for surgery, not currently have ovarian cancer, and understand they can't naturally conceive post-surgery.Inclusion Criteria
I am between 35 and 50 years old.
I have a confirmed BRCA1 mutation.
I am a woman aged between 35 and 50.
Exclusion Criteria
I am not healthy enough for my planned surgery.
I have had ovarian, peritoneal, or fallopian tube cancer before.
I have had cancer before and received chemotherapy in the last 30 days or radiation to my abdomen or pelvis at any time.
Treatment Details
The study compares two surgeries to lower ovarian cancer risk in women with BRCA1 mutations: removal of both fallopian tubes (bilateral salpingectomy) and removal of both tubes and ovaries (salpingo-oophorectomy). It includes quality-of-life assessments and regular ultrasounds.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (bilateral salpingectomy)Experimental Treatment6 Interventions
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.
Group II: Group II (bilateral salpingo-oophorectomy)Active Control6 Interventions
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.
Bilateral Salpingectomy is already approved in Canada, United States, European Union for the following indications:
🇨🇦 Approved in Canada as Opportunistic Salpingectomy for:
- Prevention of ovarian cancer
- Specifically high-grade serous carcinoma (HGSC)
🇺🇸 Approved in United States as Bilateral Salpingectomy for:
- Prevention of ovarian cancer
- Specifically high-grade serous carcinoma (HGSC)
🇪🇺 Approved in European Union as Salpingectomy for:
- Prevention of ovarian cancer
- Specifically high-grade serous carcinoma (HGSC)
Find a clinic near you
Research locations nearbySelect from list below to view details:
City of Hope SeacliffHuntington Beach, CA
Kaiser Permanente - Panorama CityPanorama City, CA
Huntington Memorial HospitalPasadena, CA
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, FL
More Trial Locations
Loading ...
Who is running the clinical trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Malignancies following bilateral salpingo-oophorectomy (BSO). [2007]Prophylactic bilateral salpingo-oophorectomy (BSO) is an effective risk reducing measure in ovarian cancer susceptible women. Yet, a small subset of women develop primary peritoneal carcinomatosis (PPC) after BSO. The rates of PPC following non-risk reducing BSO have sparingly been reported.
Risks and Benefits of Salpingectomy at the Time of Sterilization. [2022]Bilateral salpingectomy reduces the risk ovarian cancer. The Society of Gynecologic Oncology has recommended surgeons discuss salpingectomy with patients desiring sterilization.
Bilateral salpingectomy with delayed oophorectomy for ovarian cancer risk reduction: A pilot study in women with BRCA1/2 mutations. [2022]Risk-reducing salpingo-oophorectomy (RRSO) reduces ovarian cancer risk in BRCA1/2 mutation carriers, but the adverse effects of the associated early-onset surgical menopause are problematic. Despite suggestive evidence, no data demonstrate whether bilateral salpingectomy alone lowers the risk of developing ovarian cancer in BRCA mutation carriers. We conducted a pilot study of bilateral salpingectomy with delayed oophorectomy (BS/DO) in BRCA mutation carriers to determine the safety and acceptability of the procedure.
Exploring factors that impact uptake of risk-reducing bilateral salpingo-oophorectomy (RRBSO) in high-risk women. [2021]Only risk-reducing bilateral salpingo-oophorectomy (RRBSO) has been shown to reduce ovarian cancer deaths in high-risk women. Uptake of RRBSO is, however, suboptimal and reasons are not well defined. More information is needed about the barriers to RRBSO and patient needs for information and care.
Feasibility and Outcomes of Opportunistic Bilateral Salpingectomy in Patients with Traditional Relative Contraindications to Vaginal Hysterectomy. [2021]To compare the feasibility of opportunistic bilateral salpingectomy (OBS) at the time of vaginal hysterectomy (VH) for benign disease in patients with and without relative contraindications (RCs) to the vaginal approach and to evaluate the factors that contribute to the inability to perform OBS.
The effect of prophylactic bilateral salpingectomy on ovarian reserve in patients who underwent laparoscopic hysterectomy. [2023]Bilateral salpingectomy has been proposed to reduce the risk of ovarian cancer, but it is not clear whether the surgery affects ovarian reserve. This study compares the impact of laparoscopic hysterectomy for benign disease with or without prophylactic bilateral salpingectomy on ovarian reserve.
[Opportunistic Salpingectomy for Permanent Contraception: A Cross Sectional Study in Portugal]. [2021]Opportunistic bilateral salpingectomy has been proposed as an ovarian cancer risk-reducing strategy namely as a means of tubal sterilization. We aimed to assess what were the procedures for interval and peripartum sterilization carried out nationwide, related motivational aspects and influential demographic or professional factors.
Ovarian cancer incidence and death in average-risk women undergoing bilateral salpingo-oophorectomy at benign hysterectomy. [2022]Opportunistic bilateral salpingo-oophorectomy is often offered to patients undergoing benign hysterectomy to prevent ovarian cancer, but the magnitude of risk reduction obtained with bilateral salpingo-oophorectomy in this population remains unclear and must be weighed against potential risks of ovarian hormone deficiency.
Adherence to risk-reducing salpingo-oophorectomy guidelines among gynecologic oncologists compared to general gynecologists. [2023]Risk-reducing bilateral salpingo-oophorectomy reduces mortality from high-grade serous carcinoma in patients with hereditary breast and ovarian cancer associated gene mutations. Ideal surgical management includes 5 steps outlined in 2005 by the Society of Gynecologic Oncology and the American College of Obstetricians and Gynecologists. In addition, it is recommended that pathologic examination include serial sectioning of specimens. In practice, risk-reducing salpingo-oophorectomy is performed by both gynecologic oncologists and general gynecologists. To ensure optimal detection of occult malignancy, standardized adherence to outlined guidelines is necessary.