Esophageal Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Histologically proven esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, besaloid carcinoma) (2)all lesions are localized in thoracic esophagus. (3)The depth of main lesion is endoscopically diagnosed submucosa. (4)No lymphnode metastasis and no distant metastasis. (5)No prior chemotherapy and/or radiotherapy. Only curative endoscopic mucosal resection is allowed. (6)ages 20 years-75years (7)PS(ECOG) 0-1 (8)Normal organic function. (9)oral or written informed consent obtained before randomization
Exclusion criteria
Exclusion criteria: (1)synchronous or metachronous (within 5 years) malignancy (2)Pregnant or lactating (3)psychiatric medication (3)Systemic administration of steroids (4)HBsAg positive (5)Use of insulin injection therapy or uncontrolled diabetes mellitus (6)History of acute myocardial infarction (within 3 months) or unstable angina (7)Severe complecations (COPD, pulmonary fibrillation, heart failure etc.) (8)active bacterial infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate, Adverse Events | — |
Countries
Japan
Contacts
JCOG0502 Coordinating Office Gastrointestinal Oncology, National Cancer Center Hospital