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Phase II trial of gemcitabine monotherapy in the third or further line for pretreated patients with advanced non-small cell lung cancer

Phase 2
Conditions
on-small cell lung cancer
Registration Number
JPRN-UMIN000017791
Lead Sponsor
Dept.Repiratory Medicine, Osaka Police Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

1) A history of gemcitabine treatment 2) Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest X-ray film 3) Concurrent thoracic radiotherapy 4) A history of severe hypersensitivity against gemcitabine 5) Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer 6) Pleural effusion, ascites or peri-cardiac effusion requiring dranage. 7) Problematic complications 8) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 9) Decision of ineligibility by a physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression-free survival(PFS)
Secondary Outcome Measures
NameTimeMethod
Response rate (RR), Overall survival (OS), 1yr-survival rate, adverse effects, QOL assessment
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