Status:
COMPLETED
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Shandong Cancer Hospital and Institute
Collaborating Sponsors:
Chinese Academy of Medical Sciences
Peking University Cancer Hospital & Institute
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation impr...
Detailed Description
Esophageal cancer is the sixth leading cause of cancer death worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and...
Eligibility Criteria
Inclusion
- Inpatients or outpatients, ≥ 18 years of age
- Histologically confirmed primary (non-recurrent) ESCC fulfilling one of the following criteria (AJCC Staging System)
- cervical esophageal carcinoma, stage Ⅱ-Ⅲ
- upper thoracic esophageal carcinoma, stage Ⅱ-Ⅲ, or mid-thoracic esophageal carcinoma, stage Ⅱ-Ⅲ,which is medically unfit for surgery, surgery been refused and patient medically able to tolerate chemo-radiation.
- Evidence of unidimensional measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST).
- ECOG Performance status of 0-1
- Effective contraception for both male and female patients if the risk of conception exists
- Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl
- Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
- Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN
- Tumor tissue available for KRAS biomarker test
- Signed written informed consent prior to study entry
Exclusion
- Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
- Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
- Multiple primary carcinomas of the esophagus
- Pregnancy (confirmed by serum or urine β-HCG) or lactation period;
- Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
- Unable to comprehend the study requirements or who are not likely to comply with the study parameters;
- Distant metastasis
- Second malignancy, except for curable non-melanoma skin cancer, cervical cancer in situ, or malignant disease, free for ≥ 5 years
- Known grade 3 or 4 allergic reaction to any of the study treatment
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00815308
Start Date
January 1 2009
End Date
July 1 2010
Last Update
February 8 2011
Active Locations (1)
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1
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117