Clinical trial NCT02123381: Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Official title: Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Middle or Lower Thoracic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma
Keywords: tumor tissue and serum biomarkers
cetuximab
preoperative radiotherapy
esophageal squamous cell carcinoma
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Southwest Hospital, China
name: Xinqiao Hospital of Chongqing
First posted: 2014-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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;

Primary outcomes:
measure: Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
timeFrame: before radiotherapy and 1 months after the radiotherapy
measure: Expression of p53 in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
timeFrame: before radiotherapy and 1 months after the radiotherapy
measure: changes of serum vascular endothelial growth factor（VEGF）level before and after radiotherapy
timeFrame: before radiotherapy and 1 months after the radiotherapy
Secondary outcomes:
measure: Quality of life (QOL)
timeFrame: up to 3 years
measure: Overall survival
timeFrame: up to 3 years
measure: PFS（progression-free survival）
timeFrame: up to 3 years
measure: local control rate（LCR）
timeFrame: up to 3 years
measure: Pathological remission
timeFrame: 1 months after the end of surgery
measure: grade 3-5 adverse events
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: YONGTAO HAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: GE WANG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: TAIQIAN GONG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: LONG CHEN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: NAIQUAN MAO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Hospital, China
name: ZHIHUA RUAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Hospital, China
name: GANG XIONG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinqiao Hospital of Chongqing
name: JIANGUO SUN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinqiao Hospital of Chongqing
name: GUANGHUI LI, MD.PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinqiao Hospital of Chongqing
name: DEZHI LI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinqiao Hospital of Chongqing
name: MINGZHANG XIANG, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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