A clinical trial for patients with recurrent adult type granulosa cell tumors of the ovary


Currently Unavailable for Patients

About This Study

NRG-GY033 is a clinical trial for patients with adult-type granulosa cell tumors of the ovary. This trial is being done to determine if the combination of the drugs darolutamide, leuprolide acetate, and exemestane are helpful in treating your type of cancer. Though treatment on the trial could possibly shrink your cancer, it could also cause side effects.


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

Am I eligible for this study?

If you are over the age of 18, have recurrent adult-type granulosa cell tumors of the ovary, and have had prior treatment, you may be able to participate. Your healthcare team is the best source for information about your treatment options, including cancer clinical trials. Be sure to take this information to your doctor to discuss your questions and concerns in general and specific to the NRG-GY033 study.

 

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 the study? Find a participating location

 

Want more information?

Additional information for the NRG-GY033 study 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.

The NRG-GY033 Study FAQ

If you are over the age of 18, have recurrent adult-type granulosa cell tumor of the ovary, and have had prior treatment, you may be able to participate.

This study is being done to answer the following question: 
How well does the drug combination of darolutamide, leuprolide acetate, and exemestane work in treating your type of recurrent cancer?

We are doing this study because we want to find out if this approach is helpful in treating your type of ovarian cancer. This study will not directly compare this drug combination to the usual approach to treatment and therefore the study will not determine if this drug combination is better or worse than the usual approach. The usual approach is defined as care most people get for recurrent adult-type granulosa cell tumors of the ovary.


If you decide to take part in this study, you will get the drugs darolutamide, leuprolide acetate, and exemestane until your cancer gets worse or your study doctor determines that continuing in the study is not in your best interest. 

After you finish your treatment, your doctor and study team will watch you for side effects.  They will check you every 3 months for 2 years after treatment.  After that, they will check you every 6 months for 3 years.  This means you will keep seeing your doctor for 5 years after treatment.
The usual approach for patients who are not in a study is treatment with FDA-approved chemotherapy drugs. Carboplatin and paclitaxel is the preferred treatment regimen. Sometimes other combinations are used.  


If you choose to take part in this study, there is a risk that the combination of darolutamide, leuprolide acetate, and exemestane may not be as good as the usual approach at shrinking or stabilizing your cancer or preventing your cancer from coming back.  
There is also a risk that you could have side effects from the study drugs.  These side effects may be worse and may be different than you would get with the usual approach for your cancer.  
Some of the most common side effects that the study doctors know about are:
  • Anemia (which may require blood transfusion)
  • Pain
  • Constipation
  • Tiredness
  • Dizziness
  • Hot Flashes
There may be some risks that the study doctors do not yet know about.  


There is evidence that darolutamide, leuprolide acetate, and exemestane can shrink or stabilize your type of cancer. It is not possible to know now if the study drugs will extend your time without disease compared to the usual approach.  This study will help the study doctors learn things that will help people in the future.
After you finish your treatment, your doctor and study team will watch you for side effects.  They will check you every 3 months for 2 years after treatment.  After that, they will check you every 6 months for 3 years.  This means you will keep seeing your doctor for 5 years after treatment.
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.
What are the costs of participating on this study?
You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer.  
This includes:
• the costs of tests, exams, procedures, and drugs that you get during the study to monitor your safety and prevent and treat side effects.  
• your insurance co-pays and deductibles.
Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn’t pay for if you take part in this clinical trial.  Also, find out if you need approval from your plan before you can take part in the study. 
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. This would include any organization helping the company with the study. 
• The National Cancer Institute (NCI) Central Institutional Review Board, which is a group of people who review the research with the goal of protecting the people who take part in the study.
• The Food and Drug Administration and the groups it works with to review research.  
• 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, including the Imaging and Radiation Oncology Core (IROC). 

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.