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Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.

Not Applicable
Conditions
advanced squamous cell lung carcinoma
Registration Number
JPRN-UMIN000003332
Lead Sponsor
Keio University School of Medicine, division of Pulmonary Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

Exclusion Criteria

1.History of grave drug allergic reaction 2.Patients under treatment with phenytoin or flucytosine. 3.Serious complications (e.g. intestinal paralysis, intestinal obstruction, interstitial pneumonia or fibroid lung detectable on chest X-ray films , poorly controlled diabetes, heart failure, renal failure, hepatic failure, or haemorrhagic peptic ulcer etc.). Serious medical complications 4. History of poorly controlled pleural effusion,pericardial effusion and ascites . 5.Symptomatic brain metastasis 6.Patients with uncontrolled water diarrhea or chronic constipation. 7.Active double cancer. Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration. 8.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. 9.Males that are currently attempting to produce a pregnancy. 10.Inadequate physical condition, as diagnosed by primary physician.

Study & Design

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