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| Name | Class |
|---|---|
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Southwest Hospital, China |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | All patients in the arm receive cetuximab combined with preoperative radiotherapy at first. 4-6 weeks after the rdiaotherapy,patients receive right thoracotomy with three incisions radical surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Expression 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. | 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. | 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. | before radiotherapy and 1 months after the radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 3 years |
| Overall survival |
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Inclusion Criteria:
(1)18 to 65 years old,male or female (2)Pathologically or cytologically proven thoracic middle-lower esophageal squamous cell carcinoma; (3)clinical stage II or stage III; (4)Primary tumors can be measured; (5)Karnofsky score >70; (6)Estimated life expectancy of at least 12 weeks; (7)reproductive age women should ensure that before entering the study period contraception; (8)Hemoglobin≥90.0g/dL,white blood cell count(WBC)≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³; (9)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal; (10)Creatinine normal OR creatinine clearance ≥ 60 mL/min; (11)Patients have good compliance to treatment and follow-up of acceptance; (12)Forced expiratory volume in one second(FEV1) ≥ 1.5 litre or ≥ 75% of the reference value; (13)Considered operable (i.e. appropriate organ functions and ability to undergo general anesthesia); (14)No severe or uncontrolled cardiovascular disease; (15)No active uncontrolled infection;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TAO LI, MD, PhD | Contact | 86-18908178818 | litaoxmf@126.com |
| Name | Affiliation | Role |
|---|---|---|
| YONGTAO HAN, MD, PhD | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| GE WANG, MD, PhD | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital & Institute | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Xinqiao Hospital of Chongqing | OTHER |
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|
| cetuximab | Drug | 400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4 |
|
|
time from randomization to death
| up to 3 years |
| PFS(progression-free survival) | time from randomization to one of the following events, whichever comes first:
| up to 3 years |
| local control rate(LCR) | Time to locoregional failure after R0 resection | up to 3 years |
| Pathological remission | 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 | up to 3 years |
| TAIQIAN GONG, MD, PhD | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Principal Investigator |
| LONG CHEN, MD, PhD | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Principal Investigator |
| NAIQUAN MAO, MD, PhD | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Principal Investigator |
| ZHIHUA RUAN, MD, PhD | Southwest Hospital, China | Principal Investigator |
| GANG XIONG, MD, PhD | Southwest Hospital, China | Principal Investigator |
| JIANGUO SUN, MD, PhD | Xinqiao Hospital of Chongqing | Principal Investigator |
| GUANGHUI LI, MD.PHD | Xinqiao Hospital of Chongqing | Principal Investigator |
| DEZHI LI, MD, PhD | Xinqiao Hospital of Chongqing | Principal Investigator |
| MINGZHANG XIANG, MD,PhD | Xinqiao Hospital of Chongqing | Principal Investigator |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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