A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial)
Phase 3
Recruiting
- Conditions
- clinical stage I/II/III (excluding T4) thoracic esophageal cancer
- Registration Number
- JPRN-UMIN000017628
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method 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