A phase II feasibility study of surgical intervention for single station cN2 (UICC 6) non-small cell lung cancer (JNETS 0801)
Phase 2
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000013247
- Lead Sponsor
- Japan North-East Area Thoracic Oncology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
Mediastinal lymphnodes with above 20mm in their shorter diameter. cN2 with over 2 stations. General contraindication for the thoracotomy with low cardio-pulmonary function, liver or renal dysfunction and the others. Age over 76. Extra-nodal invation of cN2 nodes. Distant metastasis. Other malignancies. #1-3(UICC 6) lymphnodes swelling in left side mediastinum. preceding hemotherapy, molecular targetting therapy, thoracic radiotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Single station cN2 definition is as follows. Above 10mm and below 20mm in those diameters are evaluated as metastatic nodes by computed tomography, and such positive nodes without spreading more than 2 stations are considered single station cN2. (Regardless of the status of N1 node, PET observations and patho-cytological diagnosis for those nodes) After registration, patients with single station cN2 NSCLC will take lobectomy or pneumonectomy with systematic lymphnode dissection. In some patients, adjuvant chemotherapy after the decision of pathological stating would be recommended. Primary end points of this study are overall survival (3 and 5 years) and disease specific survival (3 and 5 years).
- Secondary Outcome Measures
Name Time Method