Does Sentinel Lymph Node Biopsy improve survival outcomes when compared to Elective Neck Dissection for early stage oral cavity cancer?

People ages 18 and older, who have a proven diagnosis of squamous cell carcinoma of the oral cavity and who are candidates for surgical intervention with SNL biopsy, complete neck dissection, or END.

This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the usual surgery in extending the time you have without cancer returning? The usual approach is defined as care most people get for this cancer.

This study has 2 parts. In the first part, doctors will try to learn the answer to question #1 above. If the answer shows that neck and shoulder function and discomfort is better in patients who have the SLN biopsy, then the study will go on to the second part, and doctors will try to answer question #2.

If you decide to take part in the study and your PET/CT scan shows that your cancer has not spread, you will be randomly assigned to one of two groups. If your imaging scan shows that your cancer has spread, you will not be able to participate in the study and your doctor will discuss other treatment options with you.

Patients assigned to Group 1 will have SLN biopsy. This involves the injection of an imaging agent in the tumor that follows the lymph system to the lymph nodes in your neck. You will then receive two imaging scans, a Planar and a SPECT/CT. The scans take about 1 to 2 hours and show the lymph nodes where the cancer may have spread (called sentinel lymph nodes). The surgeon will then remove only the sentinel lymph nodes. Patients assigned to Group 2 will receive END surgery, the usual approach to treating your cancer, during which the surgeon will remove many of the lymph nodes in your neck and they will be tested for cancer.

The usual approach for patients who are not in a study is surgery to remove the tumor and also lymph nodes in the neck, followed by radiation, radiation and chemotherapy, or no more treatment and watching, depending on the nature of the cancer in the oral cavity and whether the cancer is found in your neck lymph nodes. If your doctor recommends radiation and chemotherapy there are a number of chemotherapy drugs approved by the Food and Drug Administration (FDA) for treatment of early-stage oral cavity cancer. Your doctor can explain which treatment after surgery may be best for you. The usual approach is proven to help patients with your cancer live longer.

If you choose to take part in this study there is a risk that the SLN biopsy may not be the same as the usual approach at delaying time without cancer. SLN biopsy and END have the same types of side effects. Some of the most common side effects for surgery that the study doctors know about are: Leakage of lymph fluid called “chyle” into the neck, nerve injury and shoulder movement problems, swallowing difficulty, lung infection, and bleeding. The SLN biopsy uses an imaging agent to see the lymph system and this may cause pain or irritation at the injection site. There may be some risks that the study doctors do not yet know about.

If you agree to take part in this study, there may or may not be a direct benefit to you. There is evidence that the SLN biopsy technique causes less shoulder and neck movement problems and pain, and is effective in removing your cancer. It is not possible to know now if the SLN biopsy approach will be as good at extending your time without disease compared to the usual END approach. This study will help the study doctors learn things that will help people in the future.

After either SLN biopsy or END surgery, the doctor will talk to you about the need for additional treatment such as radiation or radiation plus chemotherapy, depending on whether cancer was found in your lymph nodes. If you had SLN biopsy and cancer was found, you will have another surgery called a complete neck dissection to remove many of the neck lymph nodes. Your doctor will assess you in the clinic at 3 weeks after surgery, then every 3 months for the first year, then every 4 months for the second year, then every 6 months for the third year, then yearly for your lifetime.

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 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 and procedures that you get during the study to monitor your safety, and prevent and treat side effects; 
• SPECT/CT for patients undergoing the SLN biopsy 
• 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 Investigational 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 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, 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).

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