Confirmatory Trial of Segmentectomy for Clinical T1N0 Lung Cancer Dominant with Ground Glass Opacity based on Thin-section Computed Tomography (JCOG1211)

Phase 3

• Conditions: 3cm or less lung cancer dominant with ground glass opacity

• Registration Number: JPRN-UMIN000011819
• Lead Sponsor: Japan Clinical Oncology Group (JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-20
• Last Update Posted: 17 October 2023
• Study Completion: 2027-09-20

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Not provided

Exclusion Criteria

1) simultaneous or metachronous (within the past 5 years) double cancers other than carcinoma in situ or mucosal carcinoma. 2) active infection requiring treatment. 3) fever higher than 38 degrees C in axillary temperature. 4) women during pregnancy, possibility of pregnancy, or breast-feeding. 5) psychiatric disease. 6) systemic steroids or immunosuppressive medication. 7) diabetes mellitus treated with insulin or poorly controlled. 8) poorly controlled hypertension. 9) history of severe heart disease, heart failure, myocardial infarction within the past 6 months, attack of angina pectoris within the past 6 months, or multiple cardiac histories. 10) interstitial pneumonitis, pulmonary fibrosis, severe pulmonary emphysema, or multiple pulmonary comorbidities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year relapse-free survival

Secondary Outcome Measures

Name	Time	Method
overall survival, relapse-free survival, proportion of local recurrence, postoperative respiratory function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, incidence of adverse events, incidence of severe adverse events