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

Phase 1

• Conditions: Clinical stage III non-small-cell lung cancer; NSCLC, unresectable

• Registration Number: JPRN-jRCTs042180077
• Lead Sponsor: Takahashi Toshiaki

Brief Summary

Weekly nab-paclitaxel plus carboplatin combined with concurrent thoracic radiotherapy is associated with a high treatment completion rate and exhibits promising safety and efficacy in elderly patients with locally advanced NSCLC. Based on these results, a randomized phase III study of chemoradiotherapy for elderly patients with locally advanced NSCLC comparing weekly nab-paclitaxel plus carboplatin with daily carboplatin (JCOG1914) is currently enrolling.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Study Completion: 2020-12-26
• Results First Posted: 2021-09-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 19

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of dose limiting toxicity, treatment completion rate

Secondary Outcome Measures

Name	Time	Method
Safety, response rate, progression free survival, 2 year survival rate, overall survival, the first site of disease progression