Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma Clinical Trial
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
| NCT number | NCT02123381 |
| Other study ID # | scch2014019 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | April 2014 |
| Est. completion date | July 2020 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | July 2020 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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; |
| Country | Name | City | State |
|---|---|---|---|
| China | Sichuan Cancer Hospital & Institute | Chengdu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Sichuan Cancer Hospital and Research Institute | Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Southwest Hospital, China, Xinqiao Hospital of Chongqing |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Quality of life (QOL) | Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) | up to 3 years | |
| Secondary | Overall survival | time from randomization to death | up to 3 years | |
| Secondary | PFS(progression-free survival) | 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 |
up to 3 years | |
| Secondary | local control rate(LCR) | Time to locoregional failure after R0 resection | up to 3 years | |
| Secondary | Pathological remission | 1 months after the end of surgery | ||
| Secondary | grade 3-5 adverse events | 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 | up to 3 years |