A clinical study comparing carbon-ion radiotherapy and surgery for small-sized peripheral non-small cell lung cancer

Phase 2

• Conditions: Small-sized peripheral non-small cell lung cancer with clinical stage IA

• Registration Number: JPRN-UMIN000023183
• Lead Sponsor: Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Brief Summary

This study confirmed safety and efficacy comparable to those reported from prior facilities.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-01
• Study Completion: 2024-01-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

All patients must NOT meet the following criteria. a)Active bacterial or fungous infection b)Simultaneous or metachronous (within the past 5 years) double cancers c)Women during pregnancy or breast-feeding d)Interstitial pneumonia, lung fibrasis or severe emphysema e)Psychosis or psychiatric condition unsuitable for carbon-ion ratiotherapy or surgery f)Systemic steroids medication g)Intractable diabetes mellitus. h)Intractable hypertension i)History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months j)Metal devices in the lesion k)Other medical or psychological condition which is unsuitable for carbon-ion radio therapy or surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Five-year overall survival

Secondary Outcome Measures

Name	Time	Method
a) Relapse-free survival, Cause-specific survival b) Local recurrence c) Adverse reaction d) Respiratory function post-surgery or carbon-ion therapy e) Length of hospital stay