Phase III Randomized Study of Radiotherapy, Paclitaxel, and Carboplatin with versus without Trastuzumab in Patients with HER2-Overexpressing Esophageal Adenocarcinoma (RTOG-1010). See the protocol summary.
Dr. Howard Safran
Principal Investigator
Why This Trial Is Important Esophageal cancer that is confined to the esophagus and nearby lymph nodes (locally advanced disease) is often treated with a combination of chemotherapy, radiation therapy, and surgery (called trimodality therapy). Although trimodality therapy sometimes cures the disease, relapses are common, and many patients ultimately die from their disease. New strategies are needed to help prevent recurrences in patients with locally advanced esophageal cancer.
Samples of tumor tissue removed during biopsy or surgery indicate that about 20 percent to 30 percent of esophageal cancers express a growth factor receptor protein called HER2 (that is, the tumors are HER2 positive). Treatment with trastuzumab (Herceptin), a drug that targets HER2, improves the survival of women with HER2-positive metastatic breast cancer, and the drug markedly decreases cancer recurrence and improves the survival of women with earlier-stage HER2-expressing breast tumors. Doctors hope that trastuzumab may likewise reduce disease recurrence and improve the survival of people with HER2-positive esophageal cancer.
A recent phase III trial involving patients with advanced gastroesophageal and gastric cancers has bolstered the case for using trastuzumab in esophageal cancer. In that trial, patients with HER2-expressing tumors that could not be removed surgically (unresectable disease) were treated with chemotherapy and trastuzumab or with chemotherapy alone. Patients who received trastuzumab were more likely to respond to treatment and lived about 2.4 months longer.
In another trial, researchers at Brown University, led by Dr. Safran, conducted a pilot study of trastuzumab combined with chemotherapy and radiation therapy followed by surgery in 19 patients with locally advanced HER2-positive esophageal cancer and showed that the combined therapy was safe. They now want to see if adding trastuzumab to potentially curative therapy will help patients avoid disease recurrence and death.
In this phase III clinical trial, people with confirmed HER2-positive locally advanced adenocarcinoma of the esophagus will be randomly assigned to receive preoperative radiation therapy and chemotherapy, with or without trastuzumab. Following surgery, patients assigned to the trastuzumab arm of the study will receive maintenance therapy with trastuzumab for 1 year. The study is designed to determine whether the addition of trastuzumab improves disease-free survival and overall survival.
"The recurrence rate in locally advanced esophageal adenocarcinoma is very high, and we can only cure about 25 percent of the patients we treat with trimodality therapy," said Dr. Safran. "In [HER2-positive] breast cancer, trastuzumab reduces recurrence by about 50 percent. So one would hope that, in patients with esophageal cancer, it will have that same reduction in recurrence."
For More InformationSee the lists of entry criteria and trial contact information or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.
An archive of "Featured Clinical Trial" columns is available at http://www.cancer.gov/clinicaltrials/featured.
NCI Cancer Bulletin for June 28, 2011 - National Cancer Institute
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