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Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Conditions
Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
tumor tissue and serum biomarkers, cetuximab, preoperative radiotherapy, esophageal squamous cell carcinoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: preoperative radiotherapy
Type: Radiation
Name: cetuximab
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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:
1. Patient who have distant metastasis
2. The primary tumor or lymph node already received surgical treatment (except for biopsy);
3. Patient who received radiotherapy for primary tumor or lymph node;
4. Patient who received the the epidermal growth factor targeted therapy;
5. Patient who received chemotherapy or immunotherapy;
6. Patient who suffered from other malignant tumor;
7. Epidermal growth factor receptor（EGFR）mutation（-）;
8. Patient who have taken other drug test within 1 month;
9. Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
10. Subject with a severe allergic history or idiosyncratic;
11. Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
12. Drug abuse or alcohol addicted;
13. Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;
(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:
1. Patient who have distant metastasis
2. The primary tumor or lymph node already received surgical treatment (except for biopsy);
3. Patient who received radiotherapy for primary tumor or lymph node;
4. Patient who received the the epidermal growth factor targeted therapy;
5. Patient who received chemotherapy or immunotherapy;
6. Patient who suffered from other malignant tumor;
7. Epidermal growth factor receptor（EGFR）mutation（-）;
8. Patient who have taken other drug test within 1 month;
9. Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
10. Subject with a severe allergic history or idiosyncratic;
11. Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
12. Drug abuse or alcohol addicted;
13. Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;
Location
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China
Status: Recruiting
Contact: TAO LI, MD, PhD - 86-18908178818 - litaoxmf@163.com
Start Date
April 2014
Sponsors
Sichuan Cancer Hospital and Research Institute
Source
Sichuan Cancer Hospital and Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page