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A phase II randomized trial of adjuvant chemotherapy for the patients completely resected pathological stage IB(T>5cm), II, IIIA Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP

Phase 2
Recruiting
Conditions
non-small cell lung cancer
Registration Number
JPRN-UMIN000001765
Lead Sponsor
Kyushu University,Graduate School of Medical Science,Department of Surgery and Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

(1)A history of severe allergic reactions to drugs (2)Patients who have already received CDDP,S-1 (3)myocardial infarction within 6 months (4)apparent interstitial pneumonitis or pulmonary fibrosis (5)Patients with an unstable or serious heart disease (6)Patients with an unstable or serious psychic disease (7)uncontrolled diabetes mellitus (8)Patients with Paralysis of intestine or ileus (9)Patients with an active infection (10)Patients with other severe complication (11)The presence of other concomitant or metachronous cancers (12)Pregnant or expecting or lactating woman (13)Male patient who intends to make someone pregnant during this study (14)Patient who requires continuous use of flucytosine , phenytoin or warfarin potassium (15)systemic steroid therapy required (16)Patient who is judged to be inappropriate as subject to this study by the principal investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2-year desease free survival rate
Secondary Outcome Measures
NameTimeMethod
overall survival,desease free survival,safety,feasibility(dose intensity included)
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