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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)

Phase 3
Recruiting
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
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) 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
NameTimeMethod
Overall survival
Secondary Outcome Measures
NameTimeMethod
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.
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