Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma
Condition: Esophageal Cancer
MeSH terms: Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Intervention: cetuximab (Erbitux); Paclitaxel; Cisplatin; Radiation
Intervention description: Cetuximab,injection,loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8); Paclitaxel,injection,loading dose 45 mg/m^2,(Day1 in every week for Weeks 2-8); Cisplatin,injection,loading dose 20 mg/m^2,(Day1 in every week for Weeks 2-8); Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).
Intervention MeSH terms: Paclitaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Therapeutic; Drug Therapy, combination; Radiotherapy

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 improve clinical outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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