Sublobar resection versus lobectomy for patients with resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708,SURPRISE trial)
- Conditions
- Resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis
- Registration Number
- JPRN-UMIN000032696
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Not provided
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) Fever of 38 degree or higher at registration 4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy 5) Severe psychological disorder 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment 7) Uuncontrollable diabetes mellitus 8) Uncontrollable hypertension 9) Unstable angina, cardiac infarction within the past 6 months 10) Uncontrollable valvular disease or uncontrollable dilated cardiomyopathy or uncontrollable hypertrophic cardiomyopathy
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 local recurrence, operation time, blood loss, proportion of acute exacerbation of IPF, postoperative respiratory function at 6 months and 1 year (FVC, FEV1.0 and %DLCO), adverse events, serious adverse events.