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A Study on the efficacy and safety of Docetaxel plus Nedaplatin in patients with advanced non-small-cell lung cancer

Phase 2
Conditions
non-small-cell lung cancer
Registration Number
JPRN-UMIN000005031
Lead Sponsor
Shiga University of Medical Science
Brief Summary

(Patients background) Enrolled patients:46 Male/Female=39/7, PS 0/1=27/19, IIIB/IV=20/27 Sq/Ad/NSCLC/AdSq=12/25/8/ Total cycles administered:144 cycles(mean:3.1 cycles) (Efficacy) CR/PR/SD/PD=0/24/11/11 Objective response rate 52.2% (24/46) (Safety) Grade 3- Leukopenia 29.2% Nausea/vomiting 3.5% Anorexia 4.2%

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1. Allergy against polysorbert 80 or platinum-containing drugs 2. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes,hemorrhagic tendency ) 3. Active infections 4. Massive pleural or pericardial effusion 5. Brain metastases with neurological symptoms. 6. Active simultaneous cancer 7. Active interstitial pneumonitis or its past history 8. Peripheral nerve disorder 9. Pregnant or lactating women 10. Other conditions not suitable for this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy
Secondary Outcome Measures
NameTimeMethod
Satety
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