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.
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
Drug | Synonyms | Arms |
---|
cetuximab | Erbitux, C225 | Arm 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
Name | Type | Description | Interventions |
---|
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. | |
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 17, 2020