Randomized phase III study to evaluate the value of omission of prophylactic neck dissection for stage I/II tongue cancer (JCOG1601, RESPOND)
Phase 3
Recruiting
- Conditions
- clinical stage I/II (T1-2N0) tongue cancer
- Registration Number
- JPRN-UMIN000030098
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
Not provided
Exclusion Criteria
1)Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 2)Active infection requiring systemic therapy 3)Body temperature >= 38 degrees Celsius 4)Women during pregnancy, within 28 days of postparturition, or during lactation. Men favoring gestation of their partners. 5)Severe psychiatric disease 6)Patients requiring systemic steroid medication or the other immunosuppressive drug excluding corticosteroid drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method