Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400114
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2006-11-15
Brief Title:
Sutent Following Chemotherapy Radiation and Surgery For Resectable Esophageal Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Adjuvant Sutent Following Chemotherapy Radiation and Surgery For Esophageal Cancer A Phase II Trial ASSET
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see whether or not the combination of cisplatin irinotecan and radiation followed by surgery followed by oral Sutent is effective and safe for patients with resectable esophageal cancer
Detailed Description:
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 chemoradiationsurgery 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None