Preventive Surgery for Ovarian Cancer

Recruiting at 8 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

374 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.

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.

What data supports the effectiveness of the treatment Surgery for Preventive Surgery for Ovarian Cancer?

Research shows that proper surgical treatment can significantly improve survival rates for patients with advanced ovarian cancer, highlighting the importance of surgery in managing the disease. ^{1 2 3 4 5}

Is preventive surgery for ovarian cancer generally safe for humans?

Surgery related to ovarian cancer screening has been shown to have a low rate of complications, with most being minor. In a study, 10% of patients experienced complications, mostly minor, and surgeries were generally well tolerated, even in repeat operations. ^{6 7 8 9 10}

How does preventive surgery for ovarian cancer differ from other treatments?

Preventive surgery for ovarian cancer, specifically prophylactic oophorectomy or salpingo-oophorectomy, is unique because it involves the removal of the ovaries and/or fallopian tubes to significantly reduce the risk of developing ovarian cancer, especially in women with genetic risk factors like BRCA mutations. Unlike other treatments that focus on managing the disease after it occurs, this surgery is a preventive measure aimed at high-risk individuals to prevent cancer from developing in the first place. ^{11 12 13 14 15}

Research Team

Roni N Wilke, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Impact of proper surgical treatment on the survival of patients with epithelial ovary cancer. [2023]

2. France pubmed.ncbi.nlm.nih.gov

[Current treatment of malignant epithelial tumors of the ovary]. [2009]

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

Clinical course of patients treated for advanced ovarian carcinoma without surgical intervention. [2021]

4. France pubmed.ncbi.nlm.nih.gov

[Management of malignant epithelial tumors of the ovary]. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Epithelial Ovarian Cancer-Varied Treatment Results. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Complications from Surgeries Related to Ovarian Cancer Screening. [2020]

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

Morbidity and mortality associated with primary and repeat operations for ovarian cancer. [2009]

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

Ovarian cancer surgery in Germany: An analysis of the nationwide hospital file 2005-2015. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety of fertility-sparing surgery in primary mucinous carcinoma of the ovary. [2021]

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

Laparoscopic treatment of early ovarian cancer: surgical and survival outcomes. [2004]

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

Prophylactic oophorectomy: clinical considerations. [2019]

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

Ovarian Cancer Prevention in High-risk Women. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Prophylactic oophorectomy: why and when? [2019]

14. Netherlands pubmed.ncbi.nlm.nih.gov

[Prophylactic surgery in common hereditary cancer syndromes]. [2013]

15. India pubmed.ncbi.nlm.nih.gov

Opportunistic Salpingectomy as an Ovarian Cancer Primary Prevention Strategy. [2019]