A phase III randomised trial of lobectomy versus limited resection (segmentectomy) for small (2 cm or less) peripheral non-small cell lung cancer (JCOG0802/WJOG4607L)

UMIN ID: UMIN000002317

Registered date:10/08/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: small (2 cm or less) peripheral non-small cell lung cancer
• Date of first enrollment: 2009/08/10
• Target sample size: 1100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Pulmonary lobectomy
B: Pulmonary segmentectomy

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: postoperative respiratory function, relapse-free survival, proportion of local recurrence, adverse events, proportion of completion of segmentectomy, days of hospitalization, duration of chest tube placement, operation time, blood loss, number of used auto-sutures.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1) Active bacterial or fungous infection. 2) Simultaneous or metachronous (within the past 5 years) double cancers. 3) Women during pregnancy or breast-feeding. 4) Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema. 5) Psychosis. 6) Systemic steroids medication. 7) Uncontrollable diabetes mellitus. 8) Uncontrollable hypertension. 9) History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Secondary Sponsor: West Japan Oncology Group (WJOG)
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development