Esophageal Cancer Clinical Trial
Official title:
Phase I/IIB Study of Induction Chemotherapy With XELOX, Followed by Radiation Therapy and Dose Escalation of RAD001 in Patients With Esophageal Cancer
The purpose of this study is to test the drug RAD001 in combination with another chemotherapy
drug, Carboplatin, as well as radiation therapy in the treatment of esophageal cancer.
Because RAD001 has not been used in this combination before, it is not clear which dose will
be best when used in combination.
The standard of care for patients who have esophageal cancer that has not moved to other
areas of the body (non-metastatic) includes a combination of chemotherapy, radiation therapy
and possibly surgery. If the patient chooses to participate in this study, the patient will
receive chemotherapy and radiation therapy. The patient will possibly also have surgery to
have the cancer removed. This decision will be made by the treating physicians. All of the
chemotherapy the patient will receive on the study is considered standard chemotherapy for
esophagus cancer. The investigators do not know as of yet if the drug called RAD001 will help
improve the treatment for patients with this disease. RAD001 is a pill that has been used in
many other types of cancer and has been proven to be effective in other cancers such as
kidney cancer.
Esophageal cancer is the sixth most common cause of cancer-related death worldwide. Recent
medical advances have led to small improvements in survival, but the overall rate of survival
remains low, making new treatment approaches necessary.
Chemotherapy drugs and radiation therapy are often both used in treating esophageal cancer.
The combination of oxaliplatin and capecitabine (XELOX) is a commonly used chemotherapy
combination. Sometimes chemotherapy is given as an "induction" therapy, before the radiation
is given.
The drug RAD001 is a targeted drug that acts specifically on a protein inside cells (called
mTOR), which is important for cancer development. The combination of RAD001 and radiation
therapy has been shown to improve anti-cancer effects.
This study will look for the ideal dose of RAD001 when given in combination with radiation
therapy after induction chemotherapy with XELOX, and test the anticancer effects of this
treatment approach in patients with esophageal cancer.
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