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

NCT02123381 | Unknown Phase 2 DMC

• 1 other identifier: scch2014019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma

Keywords

tumor tissue and serum biomarkers; cetuximab; preoperative radiotherapy; esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Quality of life (QOL)

  up to 3 years

• Overall survival

  up to 3 years

• PFS（progression-free survival）

  up to 3 years

• local control rate（LCR）

  up to 3 years

• Pathological remission

  1 months after the end of surgery

Study Arms (1)

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.

Radiation: preoperative radiotherapy; Drug: cetuximab

Interventions

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.

Arm A

cetuximab DRUG

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

Also known as: Erbitux, C225

Arm A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;

You may not qualify if:

• Patient who have distant metastasis
• The primary tumor or lymph node already received surgical treatment (except for biopsy);
• Patient who received radiotherapy for primary tumor or lymph node;
• Patient who received the the epidermal growth factor targeted therapy;
• Patient who received chemotherapy or immunotherapy;
• Patient who suffered from other malignant tumor;
• Epidermal growth factor receptor（EGFR）mutation（-）;
• Patient who have taken other drug test within 1 month;
• Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
• Subject with a severe allergic history or idiosyncratic;
• Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
• Drug abuse or alcohol addicted;
• Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Southwest Hospital, China: collaborator
• Xinqiao Hospital of Chongqing: collaborator

Study Sites (1)

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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

• 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

Central Study Contacts

TAO LI, MD, PhD

CONTACT

86-18908178818; litaoxmf@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head

Study Record Dates

• First Submitted: April 13, 2014
• First Posted: April 25, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (1)