Clinical Trials /

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

NCT02123381

Description:

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.

Related Conditions:
  • Esophageal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: scch2014019
  • NCT ID: NCT02123381

Conditions

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

Interventions

DrugSynonymsArms
cetuximabErbitux, C225Arm A

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalAll 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.
  • cetuximab

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;
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
Time Frame:before radiotherapy and 1 months after the radiotherapy
Safety Issue:
Description:Survivin, an inhibitor of apoptosis protein, is highly expressed in most cancers and associated with radiotherapy resistance, increased tumor recurrence, and shorter patient survival.

Secondary Outcome Measures

Measure:Quality of life (QOL)
Time Frame:up to 3 years
Safety Issue:
Description:Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)
Measure:Overall survival
Time Frame:up to 3 years
Safety Issue:
Description:time from randomization to death
Measure:PFS(progression-free survival)
Time Frame:up to 3 years
Safety Issue:
Description:time from randomization to one of the following events, whichever comes first: Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions) Recurrence at local, regional or distant site after surgery Death from any cause
Measure:local control rate(LCR
Time Frame:up to 3 years
Safety Issue:
Description:Time to locoregional failure after R0 resection
Measure:Pathological remission
Time Frame:1 months after the end of surgery
Safety Issue:
Description:
Measure:grade 3-5 adverse events
Time Frame:up to 3 years
Safety Issue:
Description: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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sichuan Cancer Hospital and Research Institute

Trial Keywords

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

Last Updated

March 16, 2020