clinical stage I/II/III (excluding T4) thoracic esophageal cancer
Conditions
Interventions
A: Thoracic approach
open esophagectomy via a right thoracotomy in the lateral decubitus position. Abdominal approach
open or laparoscopic approach D2 or more lymph node dissection is performed.
B: Thoracic approach
thoracoscopic esophagectomy via a right thoracoscopy in the lateral decubitus position or prone position. Abdominal approach
open or laparoscopic approach D2 or more lymph node dissection is performed.
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Staging of tumor is performed according to the UICC/AJCC 7th edition of the TNM Classification of Malignant Tumours. To be eligible for this study, patients must fulfill all of the following criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma. 2) Primary tumor located in thoracic esophagus. Tumor which is centrally located more than 2 cm below of the esophago-gastric junction is ineligible 3) Either single lesion or multiple lesions. Second tumors in cervical esophagus which is indicated for EMR/ESD are also eligible. 4) Clinical stages I, II or III (excluding T4) based on the 7th UICC-TNM classification. Patients who received preoperative chemotherapy must fulfil both i) and ii). i) Clinical stage before chemotherapy is I, II or III (excluding T4) ii) No T4 lesions or metastatic lesions are observed after chemotherapy. 5) Aged 20 to 80 years. 6) PS (ECOG) of 0 or 1. 7) No prior treatment against esophageal cancer except for i)-iii) i) Non-curative resection for primary tumor by EMR/ESD. ii) Clinical stage IB, II or III esophageal cancer patients who received 2 courses or less of cisplatin plus fluorouracil. iii) Curative resection had been achieved by EMR/ESD against metachronous multiple cancer. 8) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of adjuvant hormonal therapy after more than 1 year from the last administration is eligible 9) No prior lateral thoracotomy (or thoracoscopic surgery) on right side or no prior lobectomy or more extended surgery on left side was performed. 10) Pre-operative FEV1.0 > 1000 ml 11) Sufficient organ functions. i. WBC >= 3,000/mm3 ii. Platelet >= 100,000/mm3 iii. Hemoglobin >=10mgldL iv. T.Bil =< 1.5 mg/dL v. AST =< 100 IU/L vi. ALT =< 100 IU/L vii. Creatinine =< 1.5 mg/dL viii. SpO2 >= 95% 12) R0 esophagectomy is expected. 13) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. 5) Severe psychiatric disease. 6) Continuous systemic steroid or immune-suppressive drug therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Severe pulmonary fibrosis or emphysema. 9) Poorly controlled hypertension. 10) Poorly controlled diabetes mellitus in spite of continuous use of insulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, proportion of patients with R0 resection, proportion of patients who needed re-operation, adverse events, postoperative respiratory function, postoperative quality of life (EORTC QLQ-C30), proportion of patients who underwent conversion from thoracoscopic surgery to open surgery | — |
Countries
Japan
Contacts
Public ContactHiroya Takeuchi
JCOG1409 Coordinating Office Department of Surgery, Keio University School of Medicine
Outcome results
None listed