Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

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M.D. Anderson Cancer Center

Status

Active, not recruiting

Conditions

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

Treatments

Procedure: Salpingectomy
Procedure: Salpingo-Oophorectomy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Procedure: Oophorectomy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02760849
2015-0814 (Other Identifier)
NCI-2016-00778 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES: I. 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: I. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO. II. To estimate quality of life with ISDO compared to RRSO. III. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures. IV. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality. V. To determine the compliance with ISDO compared to RRSO. VI. To estimate the number of fallopian tube, ovarian, or primary peritoneal malignancies and other malignancies over the course of the study. 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.

Enrollment

374 patients

Sex

Female

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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, or PMS2, or EPCAM; (please note: menopause is defined as >= 12 months of amenorrhea; however, for those patients with >= 12 months of amenorrhea who may be pre-menopausal, levels of follicle-stimulating hormone [FSH], luteinizing hormone [LH], and estradiol in the pre-menopausal range will be acceptable)
  • Willing to undergo two surgical procedures (if participant chooses the ISDO arm)
  • Presence of at least 1 fallopian tube and 1 ovary; (please note: prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed)
  • Patients who have undergone a prior tubal ligation will be eligible
  • Participants may have a personal history of non-ovarian malignancy, but must: a) be without evidence of disease at enrollment b) remain premenopausal c) have completed treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) > 3 months prior to enrollment (other than non-melanoma skin cancer)
  • 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)
  • Patients must understand that they will be permanently sterilized

Exclusion criteria

  • Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer
  • Current treatment with tamoxifen or aromatase inhibitors
  • Medical comorbidities making surgery unsafe as determined by the patient's surgeon
  • 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 human chorionic gonadotropin (HCG), or best judgement 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
  • 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
  • Inability to provide informed consent
  • Inability to read or speak English

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

374 participants in 2 patient groups

Arm I (ISDO)
Experimental group
Description:
Patients undergo ISDO.
Treatment:
Procedure: Oophorectomy
Other: Quality-of-Life Assessment
Other: Laboratory Biomarker Analysis
Procedure: Salpingectomy
Arm II (RRSO)
Active Comparator group
Description:
Patients undergo RRSO.
Treatment:
Other: Quality-of-Life Assessment
Procedure: Salpingo-Oophorectomy
Other: Laboratory Biomarker Analysis

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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