Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Summary

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.

Conditions

• Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma

Interventions

RADIATION

preoperative radiotherapy

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.

DRUG

cetuximab

400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  collaborator OTHER

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  lead OTHER

Principal Investigators

• YONGTAO HAN, MD, PhD · Sichuan Cancer Hospital and Research Institute

• GE WANG, MD, PhD · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

• TAIQIAN GONG, MD, PhD · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

• LONG CHEN, MD, PhD · Affiliated Cancer Hospital & Institute of Guangzhou Medical University

• NAIQUAN MAO, MD, PhD · Affiliated Cancer Hospital & Institute of Guangzhou Medical University

• ZHIHUA RUAN, MD, PhD · Southwest Hospital, China

• GANG XIONG, MD, PhD · Southwest Hospital, China

• JIANGUO SUN, MD, PhD · Xinqiao Hospital of Chongqing

• GUANGHUI LI, MD.PHD · Xinqiao Hospital of Chongqing

• DEZHI LI, MD, PhD · Xinqiao Hospital of Chongqing

• MINGZHANG XIANG, MD,PhD · Xinqiao Hospital of Chongqing

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2020-07-31

Completion

2020-07-31

Countries

• China

Study Locations