Preventive Surgery for Ovarian Cancer

Not currently recruiting at 9 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Tamoxifen, Aromatase inhibitors

Disqualifiers: Ovarian cancer, Unsafe surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether certain surgeries can help prevent ovarian cancer in women with specific genetic mutations that increase their risk. It compares two surgical options: one removes the fallopian tubes and ovaries (RRSO), and the other removes only the fallopian tubes, with the option to remove the ovaries later (ISDO). The goal is to determine which surgery better reduces cancer risk and improves overall well-being. Women who are premenopausal and have a known genetic mutation linked to ovarian cancer risk may be suitable for this study. Participants should be willing to undergo surgery and follow-up care. As an unphased trial, this study offers a unique opportunity to contribute to important research that could shape future preventive strategies for ovarian cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently being treated with Tamoxifen or Aromatase Inhibitors.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ISDO (Interval Salpingectomy with Delayed Oophorectomy) surgery is generally well-tolerated. Studies have found no major safety concerns for women undergoing ISDO. One study even reported no negative safety issues and better outcomes for women choosing ISDO, indicating that the surgery does not cause unexpected problems and might aid in recovery.

RRSO (Risk Reducing Salpingo Oophorectomy) surgery is a common procedure used to lower the risk of ovarian cancer. Its long history of use has established its safety, with most patients handling the surgery well and serious complications being rare.

Both ISDO and RRSO surgeries aim to reduce the risk of ovarian cancer. Research has shown that they are safe options for those at high risk due to genetic factors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new surgical approaches for preventing ovarian cancer. The trial compares two surgeries: ISDO (Interval Salpingectomy with Delayed Oophorectomy) and RRSO (Risk-Reducing Salpingo-Oophorectomy). ISDO is unique because it separates the removal of fallopian tubes and ovaries into two steps, potentially reducing surgical menopause side effects while still aiming to lower cancer risk. On the other hand, RRSO is the current standard, where both the ovaries and fallopian tubes are removed in one procedure. This trial could lead to more personalized surgical options, minimizing risks and improving quality of life for women at high risk of ovarian cancer.

What evidence suggests that this trial's surgeries could be effective in preventing ovarian cancer?

Research has shown that removing the fallopian tubes, a procedure called interval salpingectomy with delayed oophorectomy (ISDO), can significantly reduce the risk of ovarian cancer. Some studies indicate a risk reduction of up to 96%, which is promising for individuals with a high genetic risk. Women who have had their fallopian tubes removed experience a 35% lower chance of developing ovarian cancer. This procedure also alleviates cancer-related stress, potentially improving mental health. In this trial, participants in Arm I will undergo ISDO, while those in Arm II will undergo risk-reducing salpingo-oophorectomy (RRSO). These findings suggest that ISDO could serve as an effective preventive option for those at risk. ^{1 2 3 4 5}

Who Is on the Research Team?

Roni N Wilke, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for premenopausal women with certain genetic mutations linked to a high risk of ovarian cancer. Participants must be willing to undergo surgery and follow-up care, not currently pregnant or within 3 months post-partum, have at least one fallopian tube and ovary, and cannot be on specific cancer medications.

Inclusion Criteria

Patients must understand that they will be permanently sterilized

I am a premenopausal woman with a genetic mutation linked to ovarian cancer.

I am willing to have two surgeries if I choose the ISDO treatment option.

Exclusion Criteria

I am currently taking tamoxifen or aromatase inhibitors.

My surgeon has deemed surgery too risky for me due to other health issues.

I am currently pregnant or have given birth in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either ISDO or RRSO surgery to prevent ovarian cancer

Surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up visits at 1 month, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Surgery

Trial Overview The study compares two surgeries: Risk Reducing Salpingo-Oophorectomy (RRSO), which removes ovaries and fallopian tubes together; versus Interval Salpingectomy with Delayed Oophorectomy (ISDO), removing only the fallopian tubes first. It aims to find out which method better reduces cancer risk while preserving sexual function and well-being.

How Is the Trial Designed?

Group I: Arm I (ISDO) Experimental Treatment 4 Interventions

Patients undergo ISDO.

Group II: Arm II (RRSO) Active Control 3 Interventions

Patients undergo RRSO.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5419880/

Risk-Reducing Salpingectomy: Let Us Be Opportunistic According to the authors' model, there is a relative 29.2% risk reduction in ovarian cancer cases with the use of salpingectomy versus tubal ...

2. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/1c8d229a-ca87-4bc1-9d80-e63a256a083a-MECA.pdf?abstractid=3716862&mirid=1

1 Interval salpingectomy and delayed oophorectomy ... Risk reducing salpingo-oophorectomy (RRSO) is an effective option to prevent ovarian cancer in high risk women, but side effects related to premature ...

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.30528

Risk‐reducing salpingectomy: Let us be opportunistic There was a significantly lower risk of ovarian cancer among women who underwent previous salpingectomy (hazard ratio [HR], 0.65; 95% confidence ...

4. mdedge.com mdedge.com/oncologypractice/article/196620/gynecologic-cancer/wisp-early-data-provide-further-support-isdo

WISP: Early data provide further support for ISDO in ... Significant decreases in cancer-related distress as measured using the Impact of Event scale were seen in both groups at 6-month follow-up after ...

5. surgonc.org surgonc.org/wp-content/uploads/2019/03/Breast-Fellows-Webinar-June-2017-Article-7.pdf

Risk-Reducing Salpingectomy: Let Us Be Opportunistic There are strong data supporting this approach, which has been demonstrated to result in a 75% to 96% decrease in ovarian cancer risk and a 50% decrease in ...