Esophageal cancer
Conditions
Interventions
Surgical resection is performed if tumor is resectable after 3 courses of induction DCF chemotherapy. If tumor is unresectable, chemoradiotherapy is performed. Tumor is re-assessed during irradiatio
Sponsors
Shizuoka Cancer Center
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) Tumor was considered to be unresectable by CT scan or palpation for the following reasons: i) The primary tumor depth was determined to be clinical T4b on the 7th UICC-TNM classification, or regional lymph nodes are suspicious of invasion into adjacent structures However, the cases with esophageal perforation, fistula, bleeding, or stenosis of airway are excluded ii) Nonregional lymph node metastasis with immovable supraclavicular nodes. However, the cases with both immovable supraclavicular nodes and celiac nodes are excluded 4) No distant metastasis except for nonregional lymph node metastasis as mentioned in 3)-ii) 5) 60 Gy of definitive irradiation is considered to be possible without excessive radiation dose for risk organ 6) Age 20-75 years 7) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 8) No prior therapy against esophageal cancer except for complete resection by EMR/ESD 9) 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, or for radical endoscopic resection for head and neck cancer or esophageal cancer 10) Adequate functioning of major organ systems 11) Written informed consent was obtained from each patient
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) Hypersensitivity for docetaxel, cisplatin or polysorbate 80 containing drug 8) Uncontrolled diabetes mellitus 9) Severe emphysema or pulmonary fibrosis 10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 3 months. 11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Response rate of DCF chemotherapy, R0 resection rate, Complete response rate of chemoradiotherapy, Adverse event during DCF chemotherapy, Treatment related death, Perioperative complications, Post-therapeutic complications | — |
Countries
Japan
Contacts
Public ContactTomoya Yokota
Shizuoka Cancer Center Division of Gastrointestinal Oncology
Outcome results
None listed