Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

NCT ID: NCT02760849

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 374 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-02
• Study Completion Date: 2041-05-31

Brief Summary

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.

Detailed Description

Primary Objectives:

1. To examine changes in female sexual function with the strategy of interval salpingectomy and delayed oophorectomy (ISDO) compared to the strategy of risk-reducing salpingo-oophorectomy (RRSO) for patients who carry genetic mutations that predispose them to ovarian cancer.

Secondary Objectives:

1. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.

2. To estimate quality of life with ISDO compared to RRSO.

3. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.

4. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.

5. To determine the compliance with delayed oophorectomy within the ISDO arm.

6. To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study.

7. To identify common themes regarding influential factors in the decision to undergo risk reducing surgery in premenopausal women at genetic high-risk for ovarian can

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients undergo ISDO.

ARM II: Patients undergo RRSO.

After completion of study treatment, patients are followed up at 1 and 6 months, 1 year, and 2 years.

Conditions

Deleterious BARD1 Gene Mutation; Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Deleterious BRIP1 Gene Mutation; Deleterious EPCAM Gene Mutation; Deleterious MLH1 Gene Mutation; Deleterious MSH2 Gene Mutation; Deleterious MSH6 Gene Mutation; Deleterious PALB2 Gene Mutation; Deleterious PMS2 Gene Mutation; Deleterious RAD51C Gene Mutation; Deleterious RAD51D Gene Mutation; Hereditary Breast and Ovarian Cancer Syndrome; Premenopausal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm I (ISDO)

Patients undergo ISDO.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Oophorectomy

Intervention Type: PROCEDURE

Undergo ISDO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Salpingectomy

Intervention Type: PROCEDURE

Undergo ISDO

Arm II (RRSO)

Patients undergo RRSO.

Group Type: ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Salpingo-Oophorectomy

Intervention Type: PROCEDURE

Undergo RRSO

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Oophorectomy

Undergo ISDO

Intervention Type: PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Salpingectomy

Undergo ISDO

Intervention Type: PROCEDURE

Salpingo-Oophorectomy

Undergo RRSO

Intervention Type: PROCEDURE

Other Intervention Names

Female Castration; Ovariectomy; Quality of Life Assessment; Tubal Excision

Eligibility Criteria

Inclusion Criteria

1. Women must be ≥ 30 and ≤ 50 years of age.

2. Premenopausal women with a documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM. Menopause is defined as ≥ 12 months of amenorrhea. However, for those patients with ≥ 12 months of amenorrhea who may be pre-menopausal, levels of FSH, LH, and estradiol in the pre-menopausal range will be acceptable.

3. Willing to undergo two surgical procedures (if chooses the ISDO arm).

4. Presence of at least 1 fallopian tube and 1 ovary. Prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed

5. Patients who have undergone a prior tubal ligation will be eligible.

6. Participants may have a personal history of non-ovarian malignancy, but must:

1. Be without evidence of disease at enrollment

2. Remain premenopausal

3. Have completed treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) > 3 months prior to enrollment (other than non-melanoma skin cancer)

7. Willingness to return to the enrolling site for the study surgical procedures, including pre-operative and post-operative care.

Patients in the ISDO arm must be willing to return to the enrolling site for yearly ovarian cancer assessment.

8. Patients must understand that they will be permanently sterilized

Exclusion Criteria

1. Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer.

2. Current treatment with Tamoxifen or Aromatase Inhibitors.

3. Medical comorbidities making surgery unsafe as determined by the patient's surgeon.

4. Women who are pregnant or post-partum (within 3 months of delivery).

• Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgment of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
• Women who become pregnant on the ISDO arm via reproductive technology can remain on study. However, data collection will be suspended during pregnancy and 3 months post-partum.

5. Women with elevated levels of CA125 (>50) or transvaginal ultrasound suggesting cancer, unless findings are consistent with endometriosis. CA125 and transvaginal ultrasounds must be the most recent, but no older than 1 year from the date of enrollment.

6. Inability to provide informed consent.

7. Inability to read or speak English.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roni N Wilke, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Siteman Cancer Center at Washington University

St Louis, Missouri, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Related Links

http://www.mdanderson.org

WISP University of Texas M D Anderson Cancer Center

Other Identifiers

2015-0814

Identifier Type: -

Identifier Source: org_study_id

NCI-2016-00778

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-0814

Identifier Type: OTHER

Identifier Source: secondary_id