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A Phase III Study Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Treated without Surgery
[Protocol 09-066]
- Full Title :
- A PHASE III TRIAL EVALUATING THE ADDITION OF CETUXIMAB TO PACLITAXEL, CISPLATIN, AND RADIATION FOR PATIENTS WITH ESOPHAGEAL CANCER WHO ARE TREATED WITHOUT SURGERY (RTOG 0436)
- Purpose :
Research has shown that esophageal cancer has genetic changes that may cause an excess of certain cell growth factors and their receptors, resulting in uncontrolled tumor growth. Cetuximab (a drug approved for treating advanced colorectal cancer and head and neck cancers) is designed to block the receptors to one of these growth factors, called epidermal growth factor.
This growth factor is important in pathways that promote tumor growth and increase the blood supply to a tumor. Blocking this receptor may help slow a tumor's growth and reduce it blood supply. Laboratory evidence suggests that blocking this receptor may also increase the sensitivity of esophageal tumors to radiation therapy.
The purpose of this study is to determine if adding cetuximab to paclitaxel, cisplatin, and radiation therapy improves survival compared to paclitaxel, cisplatin, and radiation therapy alone in patients with esophageal cancer who do not undergo surgery. Patients will be randomly assigned to receive paclitaxel, cisplatin, and radiation therapy with or without cetuximab. The effect of treatment on patients' quality of life will also be assessed.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction.
- Patients may not have been previously treated with systemic therapy.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Karyn Goodman at 212-639-3983.
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