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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251052
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Procedure: Bilateral Salpingectomy Procedure: Bilateral Salpingectomy with Oophorectomy Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2262 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : October 15, 2032
Estimated Study Completion Date : October 15, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.
Procedure: Bilateral Salpingectomy
Undergo bilateral salpingectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy.
Procedure: Bilateral Salpingectomy with Oophorectomy
Undergo bilateral salpingo-oophorectomy
Other Name: bilateral salpingo-oophorectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers [ Time Frame: Up to 20 years ]
    Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.


Secondary Outcome Measures :
  1. Health-related quality of life (QOL) [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES). The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the Female Sexual Function Index (FSFI) total score.

  2. Sexual dysfunction [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by the FSFI. Higher scores indicate better functioning for the FSFI total score.

  3. Menopausal symptoms [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by the Menopausal Symptom Checklist (MSCL). Models will also include hormonal therapy as a covariate. The MSCL total score and individual items will be compared between groups using the t-test and Wilcoxon test, respectively. The change from baseline in total score will be compared between groups at each follow-up time point. The change form baseline in the 3 items not included in the subscale scores will be compared between groups using the Wilcoxon test at each follow-up time point.

  4. Cancer distress [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by the Impact of Events Scale (IES).

  5. Estrogen deprivation symptoms [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by the FACT-ES. The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score. Models will also include hormonal therapy as a covariate.

  6. Medical decision making [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by the Shared Decision Making Questionnaire (SDM-Q-9). The SDM-Q-9 total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the SDM-Q-9 total score with treatment arm and patient characteristics such as age and race. A similar model will be used to assess the association of the Decisional Regret Scale total score with treatment arm and patient characteristics such as age, race, crossover from BLS arm, and hysterectomy status.

  7. Incidence of adverse events [ Time Frame: Up to 20 years ]
    Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Counts and frequencies will be provided for the worst grade adverse event (AE) experienced by the patient by treatment arm. The distribution of AE grade in the BLS arm will be compared to the bilateral salpingo-oophorectomy arm using a chi-square test, or Fisher's exact test if cell frequencies are < 5, at the one-sided 0.05 significance level.

  8. Medical decision making [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by the Decisional Regret Scale. The Decisional Regret Scale total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the SDM-Q-9 total score with treatment arm and patient characteristics such as age and race. A similar model will be used to assess the association of the Decisional Regret Scale total score with treatment arm and patient characteristics such as age, race, crossover from BLS arm, and hysterectomy status.


Other Outcome Measures:
  1. Cost effectiveness [ Time Frame: Up to 24 months post-surgery ]
    Will be measured by European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). A Markov model will be used to model cost.

  2. Section dysfunction [ Time Frame: Up to 24 months-post surgery ]
    Will be measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items. Each item will be analyzed separately and compared between treatment arms using a chi-square test.

  3. Health related (HR)-QOL [ Time Frame: Up to 24 months post-surgery ]
    Will examine the correlation between HR-QOL, as measured by the FACT, with menopausal symptoms, as measured by the MCL, sexual dysfunction, as measured by FSFI, and PROMIS screener and external sexual function items and cancer distress as measured by the IES. Pearson correlation coefficients will be used for correlating the FACT total score with the FSFI overall score and Impact of Events Scale total distress score. Spearman correlation coefficients will be used to assess the correlation between FACT total score and the Menopausal Symptom Checklist symptoms, FSFI, and PROMIS items.

  4. Risk-reducing medical decision making validation and assessment [ Time Frame: Up to 24 months post-surgery ]
    Measured by population-specific items examining the factors associated with the risk reducing surgical treatment choice. Will by assessed using the Risk-Reducing Medical Decision Making (RR-MDM) survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have declined or elected to defer risk-reducing salpingo-oophorectomy (RRSO) after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm)
  • At least one intact ovary and fallopian tube
  • Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required
  • Premenopausal; defined as < 12 months of amenorrhea. However, for those patients with >= 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and in the premenopausal range per local institutional standards will be acceptable
  • Concurrently planned or prior hysterectomy is permitted as long as at least one fallopian tube and one ovary had been retained
  • Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Patient must have negative urine pregnancy test within 14 days prior to registration based on local institutional policies

Exclusion Criteria:

  • Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time
  • Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
  • Patients medically unfit for the planned surgical procedure
  • Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days

    • An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary)
    • An abnormal CA-125 is defined as a level > 50 U/ml in this study population of premenopausal women if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal women who are current users of oral contraceptives
  • Women who are currently pregnant or plan to become pregnant in the future

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251052


Locations
Show Show 39 study locations
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Douglas A Levine NRG Oncology
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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT04251052    
Other Study ID Numbers: NRG-CC008
NCI-2019-07791 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-CC008 ( Other Identifier: NRG Oncology )
NRG-CC008 ( Other Identifier: DCP )
NRG-CC008 ( Other Identifier: CTEP )
UG1CA189867 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No