GA NCORP

NCORP Trials

A Study to Compare Two Surgical Procedures in Women with BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

Status
Active
Cancer Type
Ovarian Cancer
Trial Phase
Eligibility
35 - 50 Years, Female
Study Type
Prevention
NCD ID
NCT04251052
Protocol IDs
NRG-CC008 (primary)
NRG-CC008
NRG-CC008
NCI-2019-07791
Study Sponsor
NRG Oncology

Summary

This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women 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.

Objectives

PRIMARY OBJECTIVE:
I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germline mutations.

SECONDARY OBJECTIVES:
I. To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to women in the BSO arm.
II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist [MSCL]), sexual dysfunction (Female Sexual Function Index [FSFI]), and cancer distress (Impact of Events Scale [IES]) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.
III. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
IV. To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

EXPLORATORY OBJECTIVES:
I. Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items.
II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction.
III. To determine the association between health related (HR)-QOL with menopausal symptoms, as measured by the MSCL, sexual dysfunction, as measured by FSFI/PROMIS screener and external sexual function items, and cancer distress as measured by the IES.
IV. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice.

TRANSLATIONAL RESEARCH OBJECTIVE:
I. To bank tissue and blood biospecimens for future research (pending funding).

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.

GROUP II: Patients undergo bilateral salpingo-oophorectomy.

After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.