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Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)

Phase 2
Conditions
limited disease small cell lung cancer
Registration Number
JPRN-UMIN000005342
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
80
Inclusion Criteria

Not provided

Exclusion Criteria

1) synchronous or metachronous active malignancies 2) allergy to a contrast agent 3) any of the followings: i) inappropriate secretion of antidiuretic hormone (SIADH) ii) ectopic ACTH syndrome iii) Lambert-Eaton myasthenic syndrome iv) subacute cerebellar degeneration v) paraneoplastic encephalomyelitis / sensory neuropathy 4) infection requiring systemic treatment 5) fever of 38 degrees centigrade or higher within 24 hours before registration 6) pregnant or lactating women 7) psychotic disorder 8) receiving systemic steroid therapy 9) unstable angina or myocardial infarction within the past 6 months 10) uncontrolled hypertension 11) uncontrolled diabetes mellitus or administration of insulin 12) interstitial pneumonitis or lung fibrosis identified by a chest X-ray, or severe pulmonary emphysema

Study & Design

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