A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer (JCOG1109, NExT study)
- Conditions
- clinical stage IB/II/III thoracic esophageal cancer
- Registration Number
- JPRN-UMIN000009482
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 600
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Progression-free survival, R0 resection rate, response rate, pathological complete response rate, adverse events during preoperative therapy, surgical morbidity, late toxicity, serious adverse events