Ongoing Trials: A closer look at ECOG-ACRIN’s studies for patients with head and neck cancer

Researchers at the ECOG-ACRIN Cancer Research Group are leading five clinical trials that explore possible new treatments for adults with head and neck cancers. These cancers can involve the mouth, throat, voice box (larynx)—or, much more rarely, the nose/sinuses or saliva glands.   

Head and neck cancers and their standard treatments—surgery, radiation, or chemotherapy—can affect how a person looks, talks, eats, or breathes. ECOG-ACRIN researchers hope that the following studies will not only lead to a better prognosis for patients but also help reduce harmful side effects that can have a profound negative impact on quality of life.

These cancers usually begin in the squamous cells that line the mucous membranes inside the head and neck. Thus, doctors often refer to them as head and neck squamous cell carcinomas or HNSCC.

Head and neck cancer with a tumor gene mutation

Clinical trial EA3132 is for patients who have had surgery for head and neck cancer. An earlier study showed that a quarter to one-third of the patients whose tumors had a mutation in a gene known as p53 had a higher risk of cancer coming back. This trial is testing whether adding chemotherapy to radiation after surgery will help lower this risk.

This phase 2 trial is more than halfway to its goal of enrolling 189 patients.

The study is led by Robert Ferris, MD, PhD of the University of Pittsburgh/UPMC Hillman Cancer Center.

Access patient educational material for EA3132 and view the eligibility criteria.

HPV throat cancer

The EA3161 trial is for patients with HPV throat cancer that has spread to nearby tissue or lymph nodes. The usual treatment for these patients is surgery, chemotherapy, and radiation therapy. This trial seeks to determine whether adding a drug that helps the body’s immune system fight cancer to the usual treatment will improve overall survival. The drug is called nivolumab, and it is a type of immunotherapy.

This phase 3 study is also more than halfway to its goal of enrolling 636 patients.

The study is led by Nabil Saba, MD of Emory University/Winship Cancer Institute.

Access patient educational material for EA3161 and view the eligibility criteria.

Nose and sinus cancer

The standard care for nose and sinus cancer is surgery followed by radiation. Surgery can result in the need to sacrifice the eye or skull bone. The EA3163 study is based on some encouraging results from small studies for a few patients who received chemotherapy before surgery. However, a larger, randomized study like this one is needed to determine whether adding chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.

This phase 2 trial aims to enroll 82 patients.

Dr. Nabil Saba (see above) is also leading this study.

Access patient educational material for EA3163 and view the eligibility criteria.

Advanced head and neck cancer

The EA3191 trial is for patients who have had surgery and radiation for head and neck cancer, but cancer has come back, or there is new cancer in a different area of the head and neck. The usual approach for treating these patients is additional surgery, followed by chemotherapy with radiation. However, there is a great need for a less toxic alternative to this usual approach for these patients. This trial is testing whether an immunotherapy drug, pembrolizumab, may work better and result in fewer side effects.

This phase 2 study aims to enroll 282 patients.

The study is led by Dan Zandberg, MD of the University of Pittsburgh/UPMC Hillman Cancer Center.

Access patient educational material for EA3191 and view the eligibility criteria.

Watch a short video about the trial.

Advanced head and neck cancer

Clinical trial EA3202 is for patients with advanced-stage head and neck cancer that does not respond—or stops responding—to treatment. It is testing the use of drugs that help the body’s immune system fight cancer with or without chemotherapy.

This trial has two parts, phase 2 and phase 3, and aims to enroll 430 patients in total. In this design, there is a seamless transition between phases, which may allow research questions to be answered more quickly.

The study is led by Aarti Bhatia, MD, MPH of Yale University/Smilow Cancer Hospital.

Learn more about EA3202 and view the eligibility criteria.

A note about phase 2 versus phase 3 cancer trials

Source: cancer.gov

• Phase 2 trials determine if the new treatment has an effect on a certain cancer or see how the new treatment affects the body and fights cancer. The number of people taking part is usually less than 100.
• Phase 3 trials compare the new treatment (or new use of a treatment) with the current standard treatment. The number of people taking part ranges from 100 to several thousand.