Different Radiation Dose With Concurrent Chemotherapy for Thoracic Esophageal Carcinoma
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, radiation, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent form
- Age: 18-75 years
- Histological or cytologic diagnosis of esophageal squamous cell carcinoma within one month. Clinical stage T1-4 N0-1 M0-1a (AJCC 6th edition). Supraclavicular lymphatic metastasis or abdominal lymph node metastasis for mid-thoracic also can be included
- Karnofsky performance status scores: ≥70
- Without any prior anticancer therapy
- BMI≥18kg/m2 or weight loss ≤5% within 3 months
- Adequate marrow function (within 7 days): White blood cell ≥ 3×109/L,Neutrophils (ANC) ≥1.5×109/L, Platelet count ≥100×109/L, Hemoglobin ≥90g/L. Normal hepatic and renal function (within 14 days): Total bilirubin <1.5 x upper limit of normal (ULN), Alanine aminopeptidase and Aspartase aminotransferase ≤ 2.5 x ULN, creatinine ≤ 1.5xULN
- Normal cardiac and pulmonary function: Forced expiratory volume at one second (FEV1) ≥1.0 L or FEV1/FVC ≥ 50% pre FEV1; No myocardial infarction within 1 year; no symptomatic heart disease, including myocardial ischemia, congestive heart failure or uncontrolled arrhythmias, roughly normal electrocardiogram; LVEF ≥ 50%,or can receive chemoradiotherapy assessed by cardiologists
Exclusion Criteria:
- Other or mixed pathological type
- The second primary tumor of esophageal cancer located outside the radiation area
- Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula
- Mid-thoracic esophageal cancer with supraclavicular lymphatic metastasis and abdominal lymph node metastasis; other metastasis
- Within 2cm of the gastroesophageal junction
- Prior chemotherapy, prior thoracic radiation, surgical resection or target therapy of the primary tumor
- Significant medical or psychiatric illnesses that in the physician's judgment (uncontrolled coronary heart disease, cardiomyopathy and/or heart failure requiring hospitalization. Uncontrolled hypertension or history of myocardial infarction within one year. Uncontrolled diabetes mellitus. Acute bacterial or fungal infection requiring intravenous antibiotics. Acute exacerbation of chronic obstructive pulmonary disease (COPD) or other pulmonary disease requiring hospitalization influencing tumor treatment
- Refused to sign informed consent form
- Concurrent pregnancy or lactation
- History of a second malignancy other than nonmelanoma skin cancer, and cervical cancer in situ.
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
High-dose
Standard-dose
concurrent chemoradiotherapy High-dose RT:59.4 Gy in 33 fractions, 1.8 Gy per fraction, 5days/week; CT: Paclitaxel 50 mg/m2 D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After that, patients receive consolidative platinum-based 3-week chemotherapy for 2 cycles.
concurrent chemoradiotherapy Standard-dose RT:50.4 Gy in 28 fractions, 1.8Gy per fraction, 5days/week; CT: Paclitaxel 50 mg/m2 D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After that, patients receive consolidative platinum-based 3-week chemotherapy for 2 cycles.