This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who will be benefit from cetuximab combined with preoperative radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients receive intensity modulated radiation therapy(IMRT) or image-guided radiation therapy(IGRT)from week 1 to week 4,once a day, 5 times per week. Radiotherapy dose:95% gross tumor volume(GTV-T) 40Gy/20f,GTV-N 40Gy/20f,CTV-T 40Gy/20f,CTV-N 40Gy/20f.
400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China
RECRUITINGExpression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
Survivin, an inhibitor of apoptosis protein, is highly expressed in most cancers and associated with radiotherapy resistance, increased tumor recurrence, and shorter patient survival.
Time frame: before radiotherapy and 1 months after the radiotherapy
Expression of p53 in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
p53 (also known as protein 53 or tumor protein 53), is a tumor suppressor protein that in humans is encoded by the TP53 gene.p53 is important in multicellular organisms and involved in preventing cancer.
Time frame: before radiotherapy and 1 months after the radiotherapy
changes of serum vascular endothelial growth factor(VEGF)level before and after radiotherapy
Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis.
Time frame: before radiotherapy and 1 months after the radiotherapy
Quality of life (QOL)
Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)
Time frame: up to 3 years
Overall survival
time from randomization to death
Time frame: up to 3 years
PFS(progression-free survival)
time from randomization to one of the following events, whichever comes first: 1. Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions) 2. Recurrence at local, regional or distant site after surgery 3. Death from any cause
Time frame: up to 3 years
local control rate(LCR)
Time to locoregional failure after R0 resection
Time frame: up to 3 years
Pathological remission
Time frame: 1 months after the end of surgery
grade 3-5 adverse events
Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0,such as esophagitis、pneumonitis and hematologic toxicity
Time frame: up to 3 years
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