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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

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ClinicalTrials.gov Identifier: NCT02123381
Recruitment Status : Recruiting
First Posted : April 25, 2014
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Southwest Hospital, China
Xinqiao Hospital of Chongqing
Information provided by (Responsible Party):
LI TAO, Sichuan Cancer Hospital and Research Institute

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma Radiation: preoperative radiotherapy Drug: cetuximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Arm A
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

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
Other Names:
  • Erbitux
  • C225




Primary Outcome Measures :
  1. Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy [ Time Frame: before radiotherapy and 1 months after the 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.

  2. Expression of p53 in Esophageal Squamous Cell Carcinoma before and after Radiotherapy [ Time Frame: before radiotherapy and 1 months after the 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.

  3. changes of serum vascular endothelial growth factor(VEGF)level before and after radiotherapy [ Time Frame: before radiotherapy and 1 months after the radiotherapy ]
    Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis.


Secondary Outcome Measures :
  1. Quality of life (QOL) [ Time Frame: up to 3 years ]
    Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)

  2. Overall survival [ Time Frame: up to 3 years ]
    time from randomization to death

  3. PFS(progression-free survival) [ Time Frame: up to 3 years ]

    time from randomization to one of the following events, whichever comes first:

    1. Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions)
    2. Recurrence at local, regional or distant site after surgery
    3. Death from any cause

  4. local control rate(LCR) [ Time Frame: up to 3 years ]
    Time to locoregional failure after R0 resection

  5. Pathological remission [ Time Frame: 1 months after the end of surgery ]
  6. grade 3-5 adverse events [ Time Frame: up to 3 years ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123381


Contacts
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Contact: TAO LI, MD, PhD 86-18908178818 litaoxmf@126.com

Locations
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China, Sichuan
Sichuan Cancer Hospital & Institute Recruiting
Chengdu, Sichuan, China, 610041
Contact: TAO LI, MD, PhD    86-18908178818    litaoxmf@163.com   
Sponsors and Collaborators
Sichuan Cancer Hospital and Research Institute
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Southwest Hospital, China
Xinqiao Hospital of Chongqing
Investigators
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Principal Investigator: YONGTAO HAN, MD, PhD Sichuan Cancer Hospital & 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
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Responsible Party: LI TAO, Section Head, Sichuan Cancer Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02123381    
Other Study ID Numbers: scch2014019
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Keywords provided by LI TAO, Sichuan Cancer Hospital and Research Institute:
tumor tissue and serum biomarkers
cetuximab
preoperative radiotherapy
esophageal squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents