SOROCk: Comparing the Effects of Two Surgical Procedures in Ovarian Cancer Risk Reduction in Women with BRCA1 Mutations


Currently Available for Patients



  

About This Study

NRG-CC008, also known as the SOROCk Trial, is a clinical trial available to a particular group of individuals with inherited BRCA1 mutations. For these pre-menopausal individuals, the study is testing whether removal of just the fallopian tubes, with the plan to remove the ovaries at a later time, can reduce the risk of ovarian cancer to the same degree as the usual standard of care of removing both the ovaries and fallopian tubes. Surgical removal of both ovaries and fallopian tubes very effectively reduces the risk of ovarian cancer in most individuals. Researchers believe that most “ovarian” cancers first begin in the fallopian tubes, suggesting that removing only the fallopian tubes may be as good as removing both the fallopian tubes and ovaries in preventing the development of ovarian cancer, while avoiding surgically induced menopause. This has never been formally tested in a clinical trial. The study will also look at how individuals on the study feel about their quality of life.

More information about this particular study is located on ClinicalTrials.gov


Am I eligible for this study?

Individuals may be able to participate if they are premenopausal, between the ages of 35 and 50, and have an inherited BRCA1 mutation and are planning to have surgery to reduce their risk of ovarian cancer.

 

Are there other studies for which I might be eligible?

Please talk to your healthcare team to see if there are other clinical studies for which you may be a good fit. Click here if you would like to view a more detailed chart of other studies available.

 

Find a Study Location

Are you interested in joining this study? Find a participating location.

 

Want more information?

Additional information for the NRG Oncology CC008 “SOROCk” trial can be found in the Patient Study Brochure. Download the brochure here.

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Frequently Asked Questions

Below, you can find FAQs about clinical research and this particular clinical trial.

NRG-CC008 (SOROCk) FAQ

Premenopausal individuals between the ages of 35 and 50 who have an inherited BRCA1 mutation, have at least one ovary and fallopian tube and are planning to have surgery to reduce their risk of ovarian cancer.

This study will determine if the two surgical procedures are similarly effective for ovarian cancer risk reduction for individuals with BRCA1 mutations who have completed childbearing. The study will also examine what factors go into deciding which surgery to have and symptoms after surgery caused by lack of estrogen due to ovary removal. 

Everyone taking part in this study will have some type of surgery to reduce the risk of ovarian cancer. Individuals in the study will choose one of two options:

• Have their ovaries and fallopian tubes removed at the same time.
• Remove just their fallopian tubes with a plan to remove the ovaries at a later time. 

Removing the ovaries and fallopian tubes is the standard of care and has been shown to dramatically reduce the risk of ovarian cancer and decrease the risk of death in individuals with mutations. Removing the fallopian tubes only may also help to prevent ovarian cancer and this study will determine if that decreases the risk of developing ovarian cancer the same as the standard of care.

The standard of care is having surgery to remove the fallopian tubes and ovaries at the same time.

If you choose to take part in this study, there is a risk that:

• You may lose time at work or home and spend more time in the hospital or doctor’s office than usual.
• You may be asked sensitive or private questions which you normally do not discuss.
• You may have side effects from the surgery performed as a part of your study. Your doctor will review all of the potential side effects with you. It is important to tell your doctor about any side effects during the study.
If you choose to only have your fallopian tubes removed:

• You may benefit from experiencing less menopausal symptoms since you did not undergo surgical menopause.
• You may decrease your risk of ovarian cancer, but whether you will decrease your risk as much as if you had removed the ovaries at the same time as the fallopian tubes is not yet known. 
• This study may help study doctors learn things that may be of value, in the future, to other individuals at increased risk of ovarian cancer. It may improve how individuals and their physicians make decisions about how to decrease their chances of developing ovarian cancer.

The surgical procedure will occur on a single day as chosen by you and your surgeon. You will be followed once per year for up to 20 years to see if you develop ovarian cancer in the future. You will be asked to have an annual CA125 blood test and complete online surveys approximately once per year. 

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.

You and/or your insurance plan will need to pay for the costs of medical care you get while you are participating in this study, just as you would if you were getting the standard of care for your condition. The surgical procedures that are performed in conjunction with this clinical trial are considered to be standard of care and are not covered by the study. Your insurance company will determine what costs are covered and what financial responsibilities you would have as part of regular medical care.
You will not be paid for taking part in this study.
Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information and/or information about your specimens from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:
• NRG Oncology and any company supporting the study now or in the future.
• The National Cancer Institute (NCI) Central IRB, which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU).
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research.  

Clinical Studies FAQ

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

  • physician offices
  • hospitals
  • clinics

    • A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

    No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials“.

    If you decide not to take part in a clinical study, you still have other choices. Talk to your doctor about your other choices.For example:
    • You may choose to have the usual treatment approach (known as “standard of care”)
    • You may choose to take part or learn more about a different study, if one is available
    • You may choose not to be treated for cancer

     

    About NRG Oncology

    At NRG Oncology, we focus on conducting clinical studies aimed to improve current cancer care practices and the lives of cancer patients. NRG Oncology partners with more than 1,300 member sites world-wide to research ways to improve treatment standards in the cancer community. Our organization is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trial’s Network.