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A Phase I Study of Carboplatin and nab-Paclitaxel plus concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer

A Phase I Study of Carboplatin and nab-Paclitaxel plus concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer - Phase I study of CBDCA+nab-PTX+TRT with locally advanced NSCLC

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013223
Enrollment
6
Registered
2014-02-22
Start date
2013-11-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non small cell lung cancer

Interventions

Patients receive CBDCA (AUC 2) and nab-paclitaxel (35, 40, 45mg/m2) on day 1 every weeks with concurrent thoracic radiation therapy.

Sponsors

Kochi University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histologically or cytologically comfirmed non-small cell lung cancer 2) patient has an indication for concurrent chemoradiotherapy. 3) ECOG performance status of 0-2 4) patients aged 20 years or older 5) adequate bone marrow, liver, and renal functions 2weeks prior to registration: neutorophil >=1,500/mm3; platelet >=100,000/mm3; AST and ALT < 5x of upper limit of normal (ULN); total bilirubin <=1.5mg/mL; serum creatinin <=1.5 mg/dl; SpO2>90 6) a life expectancy of 3 months or more 7) written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-induced lung damage 2) complicated by infectious disease requiring intravenous administration of antifungal agents and/or antibacterial agents 3) active double cancer 4) Patients with problematic complication(s) (ex. uncontrol heart disease, serious arrhythmia) 5) pregnant or lactating women or those who declined contraception 6) Patients with severe mental illness 7) Unsuitable patients judged by the attending physician

Design outcomes

Primary

MeasureTime frame
Estimation of the recommended dose, evaluation of dose-limiting toxicity

Secondary

MeasureTime frame
safety and efficacy

Countries

Japan

Contacts

Public ContactTetsuya Kubota

Kochi University, School of Medicine Dept of Hematology and Respiratory Medicine

kubotat@kochi-u.ac.jp088-880-2345

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026