Cetuximab and Chemoradiotherapy for Locally Advanced Esophageal Cancer
Name of the Trial
Phase III Randomized Study of Chemoradiotherapy Comprising Paclitaxel, Cisplatin, and Radiotherapy With Versus Without Cetuximab in Patients With Locally Advanced Esophageal Cancer (RTOG-0436). See the protocol summary.
Dr. Mohan Suntharalingam, Dr. David Ilson, Dr. Adam P. Dicker, Dr. Lisa Kachnic, Dr. André Konski, Radiation Therapy Oncology Group; Dr. Bapsi Chakravarthy, Eastern Cooperative Oncology Group
Why This Trial Is Important
More than 16,000 Americans were diagnosed with esophageal cancer in 2008, and more than 14,000 died from the disease. Most cases of esophageal cancer are not detected until the disease has spread to nearby lymph nodes or beyond, leading to the very poor survival rate. The incidence of esophageal cancer is increasing in the United States and worldwide.
Most patients with locally advanced esophageal cancer (cancer that has spread to nearby lymph nodes) either are not candidates for surgical treatment or prefer not to undergo surgery. Such patients are often treated with a combination of chemotherapy and radiation therapy (sometimes called chemoradiotherapy). The use of chemoradiotherapy has been shown to prolong the lives of these patients when compared with radiotherapy alone; however, the prospects for long-term patient survival remain poor. Doctors want to know if adding a targeted biologic agent to chemoradiotherapy can help these patients live longer.
In this trial, patients with locally advanced esophageal cancer will all undergo chemoradiotherapy using the drugs cisplatin and paclitaxel, and half of them will be randomly assigned to also receive the biologic agent cetuximab, a monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Combining cetuximab and chemoradiotherapy has produced benefits in patients with head and neck cancer, and a phase II clinical trial of the combination for esophageal and gastric cancer showed a high response rate.
"This study should definitively answer the question of whether adding an EGFR inhibitor to chemoradiotherapy can improve response rate and survival," said Dr. Suntharalingam. "This is the first national phase III study in esophageal cancer to emerge from the NCI's intergroup task force process, in which experts from around the country agreed that this is the most pressing question to answer in terms of improving outcomes for patients with locally advanced esophageal cancer."