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Anatomical segmentectomy versus wedge resection in high-risk operable patients with clinical stage IA non-small cell lung cancer: A randomized phase III trial. (JCOG1909, ANSWER)

Phase 3
Recruiting
Conditions
clinical stage IA non-small cell lung cancer
Registration Number
JPRN-UMIN000040089
Lead Sponsor
Japan Clinical Oncology Group (JCOG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
370
Inclusion Criteria

Not provided

Exclusion Criteria

(1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis.) (2) Active infection requiring systemic therapy. (3) Fever of higher than 38.0 degrees Celsius at the time of enrollment. (4) Pregnant, possibly pregnant, within 28 days after delivery, breastfeeding female or males expecting conception of their child. (5) Psychiatric illnesses or symptoms affecting daily lives. (6) Systemic administration of steroids or immunosuppressive agents either orally or intravenously. (7) Uncontrollable diabetes (HbA1c > 8%). (8) Uncontrollable hypertension. (9) Unstable angina (diagnosis or worsening of chest pain within 3 weeks) or history of myocardial infarction within 6 months prior to enrollment. (10) Uncontrollable heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (11) Diagnoses of interstitial pneumonia, pulmonary fibrosis, or both, on chest CT.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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