cT3Br esophageal cancer Esophageal Cancer, cT3Br
Conditions
Interventions
Two courses of preoperative chemoradiotherapy with docetaxel (60 mg/m2/day, day 1), cisplatin (60 mg/m2/day, day 1) and 5-FU (600 mg/m2/day, day 1-5) repeated every 4 weeks.
Radiotherapy (Intensity m
IMRT) schedule is 41.4Gy/23fr, 5days/week, followed by surgery.
D059248,Q000601
Chemoradiotherapy, surgery
Sponsors
Mine Shinji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) Radical esophagectomy (including open, laparoscopic and robotic-assisted surgery) for cervical or thoracic esophageal cancer cT3Br, Nx, M0 or M1a is scheduled. 3) Histologically diagnosed as esophageal squamous cell carcinoma, adeno squamous cell carcinoma or basal cell carcinoma. 4) ECOG performance status of 0 or 1 5) Aged 18 to 80 years old 6) No prior therapy against esophageal cancer except for the following cases a) Complete resection by EMR/ESD (diagnosed as pT1a-EP (M1) or pT1a-LPM (M2) tumors) b) Complete resection by EMR/ESD (diagnosed as pT1a-MM (M3) tumor without lymphovascular invasion) 7) Adequate organ functions 8) Laboratory tests performed within 14 days prior to enrollment meet the criteria. 1 Neutrophil count >= 1500 mm3, = 10x104 /mm3 3 Hemoglobin >= 10.0 g/dL 4 Total Bilirubin =40 mL/min, or eGFR>=40 mL/min/1.73m3 8 SpO2 >=93%
Exclusion criteria
Exclusion criteria: 1)Active infection requiring systemic therapy 2)Body temperature of 38 degrees Celsius or higher 3)Pregnant or lactating women, women of childbearing potential, or men who wish to get their partner pregnant during the treatment period. 4)Psychiatric disease or symptom 5)Patients requiring systemic steroids medication 6) Poorly controlled diabetes mellitus 7) Poorly controlled hypertension 8) Unstable angina, or with a historu of myocardial infarction within 6 monthes 9) Pulmonary fibrosis, severe emphysema, or acute heart failure 10) Cerebral infarction within 6 months 11)The patient has an active overlapping cancer. 12)Patients who are judged to be unsuitable as research subjects by the principal investigator (co-investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Completion rate of scheduled chemoradiotherapy and operation within defined period PhaseII: 2years Progression-free survival ( from the start of protocol treatment to the 24-month point) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)R0 resection rate 2) Overall Survival 3)Pathological CR rate 4)Completion rate of scheduled chemoradiotherapy and operation within defined period 5)operative morbidity 6)initial recurrent site 7)Response rate 8)Adverse event rate (CTCAE ver5.0 grade>=2) | — |
Contacts
Public ContactMotomi Nasu
Juntendo University Hospital
Outcome results
None listed