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Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0803/WJOG4307L)

Phase 3
Conditions
non-small-cell lung cancer
Registration Number
JPRN-UMIN000001424
Lead Sponsor
Japan Clinical Oncology Group(JCOG)
Brief Summary

See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
380
Inclusion Criteria

Not provided

Exclusion Criteria

1) Symptomatic brain metastasis 2) Active another neoplams 3) Severe SVC syndrome 4) Massive pericardial, pleural effusion, or ascites 5) Bone metastasis emergent for palliative radiotherapy or surgery 6) Uncontrollable systemic hypertension 7) Heart failure, Unstable angina, Myocardial infarction within 6 months 8) Uncontrollable diabetes 9) Active infection other than viral hepatitis 10) Hepatitis B virus infection 11) Interstitial pneumonia/ Pulmonary fibrosis 12) Hypersensitivity for polysolbate 80 13) Systemic administartion of corticosteroids

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
overall survival
Secondary Outcome Measures
NameTimeMethod
adverse events, progression-free survival, response rate, complete response rate, Symptom Score
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