clinical stage IB/II/III thoracic esophageal cancer
Conditions
Interventions
A: Two courses of preopeartive chemotherapy with cisplatin (80 mg/m2/day, day 1) and 5-FU (800 mg/m2/day, day 1-5) repeated every 3 weeks followed by surgery
B: Three courses of preoperative chemothe
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 lesion located in the thoracic esophagus 3) Clinical stage IB, II, III (excluding T4) based on the 7th UICC-TNM classification 4) Aged 20 to 75 years old 5) ECOG performance status of 0 or 1 6) Measurable lesions not required 7) No prior therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM(M2)/T1a-MM(M3) disease or pT1a-MM(M3) disease without vascular infiltration 8) No prior chemotherapy, radiotherapy or hormonal therapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval 9) Adequate organ functions 10) R0 esophagectomy is judged as possible by open (or laparoscopic) thoracotomy and laparotomy 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curatively resected by local therapy 2) Active infection requiring systemic therapy 3) Positive HBs antigen, HCV antibody or HIV antibody 4) Pregnant or lactating women or women of childbearing potential 5) Psychiatric disease 6) Patients requiring systemic steroids medication 7) Requiring continuous administration of flucytosine, phenytoin or warfarin potassium 8) Iodine hypersensitivity 9) Hypersensitivity for docetaxel, cisplatin or polysorbate 80 containing drug 10) Diabetes mellitus with HbA1c of 6.5%(JDS),6.9%(NGSP)or higher 11) Severe emphysema or pulmonary fibrosis 12) Poorly controlled hypertension 13) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, R0 resection rate, response rate, pathological complete response rate, adverse events during preoperative therapy, surgical morbidity, late toxicity, serious adverse events | — |
Countries
Japan
Contacts
Public ContactKen Kato
JCOG1109 Coordinating Office Gastrointestinal Oncology, National Cancer Center Hospital
Outcome results
None listed