NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042180077

Registered date:11/03/2019

A phase I study of chemoradiotherapy using CBDCA + nab-PTX for elderly stage III NSCLC

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedClinical stage III non-small-cell lung cancer
Date of first enrollment07/11/2014
Target sample size33
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Chemotherapy, thoracic radiotherapy

Outcome(s)

Primary OutcomeFrequency of dose limiting toxicity, treatment completion rate
Secondary OutcomeSafety, response rate, progression free survival, 2 year survival rate, overall survival, the first site of disease progression

Key inclusion & exclusion criteria

Age minimum>= 75age old
Age maximumNot applicable
GenderBoth
Include criteria1) Non-small cell lung cancer (NSCLC) diagnosed by cytological or histological examination 2) Unresectable locally advanced NSCLC (stage III) 3) Possible for definitive radiotherapy 4) No previous chemotherapy and thoracic radiotherapy 5) At least one measurable lesion 6) Age75 years or more 7) ECOG performance status 0-1 8) Sufficient major organ function 9) Life expectancy; at least 90 days 10) Written informed consent
Exclude criteria1) Active double cancer 2) Severe infections or complications 3) HBs antigen positive 4) Previous thoracic radiotherapy 5) Interstitial pneumonia or fibrosis on CT 6) Severe emphysema, chronic bronchitis, asthma 7) History of drug-induced pneumonia or severe drug allergies 8) Uncontrolled diabetes despite continuing treatment of insulin 9) Unstable angina or myocardial infarction within 6 months 10) Obvious abnormality of the electrocardiogram 11) Grade 2 or higher peripheral neuropathy 12) Febrile more than or equal to 38 degrees 13) Systemic use of corticosteroid or immunosuppressive drug 14) Severe mental illness 15) Unsuitable for enrollment judged by attending physician

Related Information

Contact

Public contact
Name Shota Omori
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail s.omori@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Toshiaki Takahashi
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail t.takahashi@scchr.jp
Affiliation Shizuoka Cancer Center