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Trial Title:
Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
NCT ID:
NCT02123381
Condition:
Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Cetuximab
Conditions: Keywords:
tumor tissue and serum biomarkers
cetuximab
preoperative radiotherapy
esophageal squamous cell carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
preoperative radiotherapy
Description:
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 group label:
Arm A
Intervention type:
Drug
Intervention name:
cetuximab
Description:
400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4
Arm group label:
Arm A
Other name:
Erbitux
Other name:
C225
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sichuan Cancer Hospital & Institute
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
TAO LI, MD, PhD
Phone:
86-18908178818
Email:
litaoxmf@163.com
Start date:
April 2014
Completion date:
July 2020
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Southwest Hospital, China
Agency class:
Other
Collaborator:
Agency:
Xinqiao Hospital of Chongqing
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02123381
