13
Participants
Start Date
March 31, 2009
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2013
intensity modulated radiation therapy
"All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy.~Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme.~Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan."
RAD001 (everolimus) + Cisplatin
"All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy.~Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme.~Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan."
Memorial Sloan-Kettering Cancer Center, New York
Collaborators (1)
Novartis Pharmaceuticals
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER