The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
cetuximab initial dose 400 mg/m2 iv 1 week before start radiotherapy and subsequent weekly doses of 250 mg/m2 iv for the duration of the radiation treatment
45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk
UMC Utrecht
Utrecht, Netherlands
pathological complete remission
determination of tumor residual cell content in surgical specimen
Time frame: 1 month
Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment
Time frame: 6 months
Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0
Time frame: 5 months
Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures
Time frame: 4 weeks
Progression free survival and overall survival
Time frame: 5 years
Define local (locoregional lymphnode metastasis as defined by TNM classification/ malignant peritonitis/ solid masses within the anatomic region of the esophagus) vs distant metastases as first manifestation of recurrence
Time frame: 5 years
The number of R0 resection determined by the pathologist
Time frame: after surgery
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