esophageal neoplasm
Conditions
Interventions
Chemoradiotherapy consists of 5-FU (1,000 mg/m2, day1-4, day29-32), cisplatin (75 mg/m2, day1,29) and radiotherapy (50.4 Gy/28Fr), followed by adittional two courses chemotherapy with 5-FU (1,000 mg/m
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma 2) All lesions located in the thoracic esophagus 3) Clinical stageII or III without T4 4) Aged 20 to 75 years old 5) ECOG Performance status 0 or 1 6) No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM(pM2)/pT1a-MM(M3) disease or pT1a-MM(M3) disease without vascular infiltration 7) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval 8) Adequate organ functions 9) Patients do not have a preference to receive a surgical resection as an initial therapy including preoperative chemotherapy, but agree to receive a salvage treatment including surgery when the disease is residual or recurrent 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Active infection requiring systemic therapy 3) fever over 38 degrees Celsius 4) Pregnant or lactating women or women of childbearing potential 5) Psychosis 6) Patients requiring systemic steroids medication 7) Serum HBs antigen positive 8) Diabetes mellitus with HbA1c of 7.0% or higher 9) Uncontrollable hypertention 10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months. 11) Interstitial pneumonia, fibroid lung, or severe emphysema 12) With a history of cerebrovascular disorder within 6 months 13) Drug allergy for iodic drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of 3-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, complete response rate, adverse events, delayed toxicity, salvage treatment related toxicity, esophagectomy-free survival | — |
Countries
Japan
Contacts
Public ContactYoshinori Ito
JCOG0909 Coordinating Office National Cnacer Center Hosipital, division of radiation oncology
Outcome results
None listed