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

JRCT ID: jRCTs042180077

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Clinical stage III non-small-cell lung cancer
• Date of first enrollment: 07/11/2014
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Chemotherapy, thoracic radiotherapy

Outcome(s)

• Primary Outcome: Frequency of dose limiting toxicity, treatment completion rate
• Secondary Outcome: Safety, 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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Takahashi Toshiaki
• Secondary ID(s): UMIN 000014764