Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
This study aims at developing a novel strategy to optimize the treatment of oesophageal
adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. Surgery in
combination with peri-operative chemotherapy, using the combination epirubicin, cisplatin
and 5-FU, as defined by the recent MAGIC trial, results in 13% increase in 5-yr survival. To
improve the outcome of patients with this disease we hypothesize that the addition of
pre-operative combined cetuximab-radiotherapy (cetux-RT) treatment could improve the outcome
of this patient category through better local control.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
pathological complete remission
determination of tumor residual cell content in surgical specimen
1 month
No
M. P. Lolkema, MD/PhD
Principal Investigator
UMC Utrecht
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
NL23124.041.08
NCT00827671
March 2009
August 2010
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