Risk-Reducing Surgery for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Roni Wilke, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Postmenopausal, Ovarian cancer, Legally incapable, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Risk-Reducing Salpingo-Oophorectomy (RRSO) for preventing ovarian cancer?

Research shows that Risk-Reducing Salpingo-Oophorectomy (RRSO) is highly effective in reducing the risk of ovarian and breast cancer in women with BRCA1 or BRCA2 mutations, making it a beneficial preventive treatment for those at high risk.

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Is risk-reducing surgery for ovarian cancer generally safe for humans?

Risk-reducing salpingo-oophorectomy (RRSO) is considered a safe intervention for preventing ovarian cancer in women at high risk, but it can lead to premature menopause, which may affect cognitive function and quality of life.

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How is the treatment Risk-Reducing Salpingo-Oophorectomy (RRSO) unique for ovarian cancer prevention?

Risk-Reducing Salpingo-Oophorectomy (RRSO) is unique because it is the most effective surgical option to significantly lower the risk of ovarian and breast cancer in women with BRCA1 or BRCA2 mutations, by removing the ovaries and fallopian tubes before cancer develops.

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Eligibility Criteria

This trial is for premenopausal women aged 25-50 with specific genetic mutations (BRCA1, BRCA2, BRIP1, RAD51C/D) who have completed childbearing and have at least one fallopian tube. It's not for those with a history of ovarian cancers or currently in cancer treatment.

Inclusion Criteria

I am within the age range specified for my specific genetic mutation.

Informed consent must be obtained and documented

I have at least one fallopian tube.

Exclusion Criteria

I am currently being treated for cancer.

I have had ovarian, fallopian tube, or peritoneal cancer.

I have had both of my fallopian tubes surgically removed.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo risk-reducing salpingectomy with delayed oophorectomy or risk-reducing salpingo-oophorectomy

Varies based on individual treatment plan

Follow-up

Participants are monitored for safety, ovarian cancer incidence, and other secondary outcomes

5-10 years

Exploratory Analysis

Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers

Participant Groups

The study compares two preventive surgeries for high-risk women: immediate removal of fallopian tubes and ovaries (RRSO) versus just the tubes first then ovaries later (RRS with delayed RRO). The goal is to see if delaying ovary removal affects cancer incidence.

Group I: Risk-Reducing Salpingo-Oophorectomy-RRSO Experimental Treatment 1 Intervention

Can help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO)

Group II: Risk-Reducing Salpingectomy-RRS Experimental Treatment 1 Intervention

Can help to lower the risk of ovarian cancer with a delayed removal of 1.

Group III: Risk-Reducing Oophorectomy-RRO Experimental Treatment 1 Intervention

Can help to lower the risk of ovarian cancer removing both fallopian tubes.

Risk-Reducing Oophorectomy-RRO is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Risk-Reducing Oophorectomy for:

• Ovarian cancer prevention in high-risk individuals
• Breast cancer prevention in high-risk individuals

🇪🇺 Approved in European Union as Risk-Reducing Oophorectomy for:

• Ovarian cancer prevention in high-risk individuals
• Breast cancer prevention in high-risk individuals

🇨🇦 Approved in Canada as Risk-Reducing Oophorectomy for:

• Ovarian cancer prevention in high-risk individuals
• Breast cancer prevention in high-risk individuals

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Washington University School of Medicine Saint Louis, MO

Fred Hutch/University of Washington/Seattle Children's Cancer Consortium Seattle, WA

Harvard Cancer Center Boston, MA

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Specifying the ovarian cancer risk threshold of 'premenopausal risk-reducing salpingo-oophorectomy' for ovarian cancer prevention: a cost-effectiveness analysis. [2022] Risk-reducing salpingo-oophorectomy (RRSO) is the most effective intervention to prevent ovarian cancer (OC). It is only available to high-risk women with >10% lifetime OC risk. This threshold has not been formally tested for cost-effectiveness.

2. United States pubmed.ncbi.nlm.nih.gov

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.

3. United States pubmed.ncbi.nlm.nih.gov

Single-port risk-reducing salpingo-oophorectomy with and without hysterectomy: surgical outcomes and learning curve analysis. [2010] Based on considerable prospective data, risk-reducing salpingo-oophorectomy (RRSO) is one of the most beneficial interventions available to reduce ovarian/breast cancer risk in BRCA carriers and high-risk women. The purpose of this study was to describe the initial surgical outcomes and learning curve analysis associated with laparoendoscopic single-site (LESS) RRSO with and without hysterectomy.

4. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of risk reduction estimates associated with risk-reducing salpingo-oophorectomy in BRCA1 or BRCA2 mutation carriers. [2022] Risk-reducing salpingo-oophorectomy (RRSO) is widely used by carriers of BRCA1 or BRCA2 (BRCA1/2) mutations to reduce their risks of breast and ovarian cancer. To guide women and their clinicians in optimizing cancer prevention strategies, we summarized the magnitude of the risk reductions in women with BRCA1/2 mutations who have undergone RRSO compared with those who have not.

5. United States pubmed.ncbi.nlm.nih.gov

Very high uptake of risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers: A single-center experience. [2022] Risk-reducing salpingo-oophorectomy (RRSO) is the only effective surgical strategy to reduce the increased risk of epithelial ovarian cancer in BRCA1/2 mutation carriers. Given the long-term health consequences of premature surgical menopause, we need insight in uptake and timing of RRSO to guide us in improving healthcare.

6. United States pubmed.ncbi.nlm.nih.gov

Pathologic findings and clinical outcomes in women undergoing risk-reducing surgery to prevent ovarian and fallopian tube carcinoma: A large prospective single institution experience. [2020] Risk-reducing salpingo-oophorectomy (RRSO) is recommended for women at increased risk of ovarian, fallopian tube (FT), and peritoneal carcinoma (collectively OC). We describe rates of occult neoplasia in the largest single-institution prospective cohort of women undergoing RRSO, including those with mutations in non-BRCA homologous repair (HRR) genes.

7. United States pubmed.ncbi.nlm.nih.gov

Short-term impact of surgically induced menopause on cognitive function and wellbeing in women at high risk for ovarian cancer following risk-reducing bilateral salpingo-oophorectomy. [2021] Risk-reducing bilateral salpingo-oophorectomy (RRSO) is an effective strategy to prevent pelvic serous carcinoma for women at high risk of developing ovarian cancer; however, it results in premature menopause. Data is lacking to adequately counsel these women about potential effects of premature menopause on cognition and quality of life.

8. England pubmed.ncbi.nlm.nih.gov

Fatigue and quality of life after risk-reducing salpingo-oophorectomy in women at increased risk for hereditary breast-ovarian cancer. [2019] Risk-reducing salpingo-oophorectomy (RRSO) is the safest intervention for prevention of ovarian cancer in women at increased risk for hereditary breast-ovarian cancer. Little is known about other effects of RRSO. The objective of this study was to investigate quality of life (QoL) and fatigue in a sample of women who had RRSO for increased cancer risk and to compare the findings with those of age-matched controls from the general population (NORM).