Comparing Proton Therapy to Photon Therapy for Liver Cancer

If you are 18 years or older with hepatocellular carcinoma (liver cancer), you may be able to participate.

The purpose of this study is to compare two kinds of radiation: proton therapy or photon therapy. Photon therapy, which uses high-energy x-rays to send the radiation inside the body to the tumor, is the most common radiation treatment approach for liver cancer. The other type of radiation is proton therapy, which uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor. This is the type of radiation therapy being studied in this trial. Because protons act differently inside the body than x-rays, proton radiation may result in better survival. Both photon and proton therapy precisely deliver radiation to the tumor and use special images to help guide accurate delivery of a full dose of radiation to the tumor without damaging much of the healthy tissue around it. This study will allow the researchers to know if proton radiation is better, the same, or worse than photon radiation. To be better, 40 out of 100 patients should be alive two years after starting treatment.

All patients will be randomly assigned to two separate treatment groups. Group 1 will receive proton radiation therapy for the usual length of time at the usual total dose for this type of cancer, as recommended by your treating physician. This may be 5 treatments over two weeks or 15 treatments over three weeks. Group 2 will receive photon radiation therapy for the usual length of time at the usual total dose for this type of cancer, as recommended by your treating physician. This may be 5 treatments over two weeks or 15 treatments over three weeks.

The most common way to treat your cancer is with surgery, chemotherapy, and radiation therapy. There are several FDA-approved chemotherapy drugs that are commonly used along with the radiation therapy. For patients who receive the usual approach for this cancer, about 0 out of 100 are free of cancer at five years.

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. 
• The study approach may not be as good as the usual approach for your cancer. 
• The study approach used on this trial may cause side effects. 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 so that they may be treated and so that potential adjustments to the study approach may be made.

It is not possible to know at this time if the study approach is better than the usual approach so this study may or may not help you. This study will help researchers learn things that will help people in the future.

You will receive radiation for the usual length (5 or 15 treatments over a period of 15 to 24 days) unless you can no longer tolerate the treatment. After you finish the radiation therapy, your doctor will continue to watch you for side effects and follow your condition for 5 years.

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 health plan/insurance company will need to pay for the radiation therapy, and all of the other costs of treating your cancer while in this study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge.

Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. Once you register for this study, your healthcare team will find out if your health insurance will pay for proton radiation to the liver. If it does not, you will need to decide if you want to continue participation in this study without insurance coverage if you are randomized to the proton group.

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 (study sponsor). 
• The National Cancer Institute (NCI) Central Investigation Review Board (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 US Food and Drug Administration (FDA) and the groups it works with to review research. 
• The NCI and the groups it works with to review research. 
• Other organizations in the National Clinical Trials Network (NCTN): Alliance for Clinical Trials in Oncology (ALLIANCE), ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), SWOG, and Imaging and Radiation Oncology Core (IROC).• The Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP), which is a grant-funding entity that fosters novel approaches to biomedical research in response to the needs of the American public, the military and Congress.

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".

• 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