IMRT feasibility study for stage III NSCLC

JRCT ID: jRCTs042180119

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Clinical stage 3 non-small-cell lung cancer
• Date of first enrollment: 13/01/2016
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Intensity modulated radiotherapy, chemotherapy

Outcome(s)

• Primary Outcome: Completion rate of treatment
• Secondary Outcome: Overall survival, Progression free survival, Toxicities

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1)Non-small cell lung cancer(NSCLC) diagnosed by cytological or histological examination
2)Inoperable
3)Clinical stage 3 NSCLC, possible for definitive radiotherapy
4)No previous chemotherapy or radiotherapy
5)Measurable lesions
6)Age; 20 -75 years old
7)ECOG performance status:0-1
8)Ingestible
9)Sufficient function in bone marrow, heart, lung, liver and kidney
10)Written informed consent

Exclude criteria

1)Active double cancer
2)Severe infection or morbidity
3)HBs antigen positive
4)Previous thoracic radiotherapy
5)Interstitial pneumonia or fibrosis on CT
6)Severe emphysema or chronic bronchitis or asthma
7)Severe drug allergy
8)Severe diabetes
9)Unstable angina or myocardial infarction within 6 months
10)Febrile more than or equal to 38 degree
11)Systemic use of corticosteroid or immunosuppressive drug
12)Expectant mother or breast feeding woman or not agreed with contraception
13)Psychiatric disorder
14)Unsuitable for enrollment judged by attending physician

Related Information

• Primary Sponsor: Harada Hideyuki
• Secondary Sponsor: Nishimura Yasumasa
• Secondary ID(s): R000020049