Esophageal Cancer
Conditions
Interventions
Chemoradiotherapy(5-FU+CDDP+RT) Surgery
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Historically proven squamous cell or adeon-squamous cell carcinoma. 2)Thoracic esophageal cancer 3)Clinical T2-3N0M0 or T1-3N1M0 (UICC6th) 4)Age more than 20years and less than 75 years. 5)ECOG performance status of 0,1 or 2. 6)Patients who had any evaluable lesion. 7)No prior therapy for esophageal cancer except curative endoscopic therapy. 8)No prior chemotherapy or radiotherapy for other cancr. 9)No palsy of recurrent nerve 10)Required baseline laboratory parameters (within 7 days before registration): Hb more than 10.0g/dl Neutrophil more than 2000/ul Plt more than 100,000/ul T-Bil less than 1.5mg/dl GOT less than 100 IU/l GPT less than 100 IU/l Ccr more than 60mg/min 11)The patients who were considered to be undergone transthoracic esophagectomy with D2 lymphonode dissection. 12)Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1)active other malignancies within 5 years 2)Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse. 3)Unsuitable mental status and condition for clinical trials. 4)Patients who received ontinuous steroids (orally or intravenous) administration. 5)Positive HBsAg. 6)Unstable diabetes mellitus with oral hypoglycemic agent or insulin. 7)Acute myocardial infarction within 3 months 8)severe complications (COPD, interstitial lung disease, pulmonary fibrosis, heart failure and so on) 9)clinically significant infectious disease(body temperature less than 38.0 degrees) 10)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion proportion of curative surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, curative resection rate, Response rate for CRT Pathological CR rate Acute toxicity Late toxicity Surgical toxicity | — |
Countries
Japan
Contacts
Public ContactJun Hashimoto
National Cancer Center Hospital Gastrointestinal Oncology Division
Outcome results
None listed