A non-randomized confirmatory study of Limited Surgical Resection for Peripheral Early Lung Cancer Defined with Thoracic Thin-section Computed Tomography (JCOG0804/WJOG4507L)

UMIN ID: UMIN000002008

Registered date:26/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: small (2 cm or less) peripheral radiological non-invasive lung cancer
• Date of first enrollment: 2009/05/26
• Target sample size: 330
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Limited pulmonary resection

Outcome(s)

• Primary Outcome: Relapse-free survival
• Secondary Outcome: overall survival, proportion of local recurrence, postoperative respiratory function, proportion of completion of limited resection, adverse events.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1) simultaneous or metachronous (within the past 5 years) double cancers. 2) interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema. 3) active bacterial or fungous infection. 4) women during pregnancy or breast-feeding. 5) psychiatric disease. 6) systemic steroids 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 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