obectomy versus Segmentectomy for Clinical Stage IA3 Pure-solid Non-small Cell Lung Cancer: a Phase III Randomized Trial (STEP UP trial) (WJOG 16923L)

Phase 3

Recruiting

• Conditions: clinical stage IA3 peripheral pure-solid non-small cell lung cancer

• Registration Number: JPRN-UMIN000052064
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Last Update Posted: 23 April 2024
• Study Completion: 2035-01-11

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 520

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) Local or systemic active infection requiring treatment. 3) Pregnant, lactating, possibly currently pregnant. 4) Psychosis. 5) Systemic administration of steroids or immunosuppressive agents. 6) Patient who has severe drug allergy. 7) Comorbidities (i) Diagnoses of interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema. (ii) Uncontrollable diabetes (HbA1c > 8%). (iii) Uncontrollable hypertension. (iv) Unstable angina or history of myocardial infarction within 6 months prior to enrollment. (v) Uncontrollable heart valve disease, dilated cardiomyopathy, or 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, postoperative respiratory function at 6 months and 1 year (FVC and FEV1.0), proportion of respiratory failure, proportion of cerebrovascular disease, cumulative incidence of death from other than primary lung cancer, cumulative incidence of local recurrence, proportion of patients who complete segmentectomy, number of resected segments, operative time, blood loss, adverse events.