Trial Information

Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)

Survival outcomes for resectable esophageal cancer remain poor. Current data strongly
support an adjuvant systemic strategy to improve time to progression and survival in this
patient population. Adding a well-tolerated oral targeted therapy such as Sutent, after a
combined chemo/radiation/surgery approach in this patient population has the potential to
impact on the minimal residual disease left behind by relatively effective pre-operative
chemoradiation and surgery. This has the potential to improve survival. The primary
endpoint is to determine the feasibility and efficacy of adjuvant Sutent therapy (SU11248)
after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal
radiotherapy plus surgery for potential resectable esophageal cancer. Preclinical and
clinical data suggest that Sutent will have activity in esophageal cancer, as the results of
Sutent activity in solid tumors appear to be superior to the results of other antiangiogenic
compounds in development for esophageal cancer. Therefore, by extrapolation from promising
phase I, II and III Sutent trials we propose to translate the target effects achieved with
Sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal
cancer.