MedPath

The Feasibility Study of Adjuvant Chemotherapy with TS-1+Carboplatin followed by TS-1 maintenace in Patients with Completely Resected Stage II-IIIA Non-Small-Cell Lung Cancer

Phase 1
Conditions
on-small-cell lung cancer
Registration Number
JPRN-UMIN000005041
Lead Sponsor
Setouchi Lung Cancer Group
Brief Summary

Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4-71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
89
Inclusion Criteria

Not provided

Exclusion Criteria

1. Allergy against platinum-containing drugs or component of S-1 2. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, uncontrolled diabetes, ileus, diarrhea, hemorrhagic tendency) 3. Active infections 4. Massive pleural or pericardial effusion 5. Active simultaneous cancer 6. Active interstitial pneumonitis or its past history 6. Pregnant or lactating women 8. Other conditions not suitable for this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Feasibility
Secondary Outcome Measures
NameTimeMethod
disease free survival, overall survival
Âİ Copyright 2025. All Rights Reserved by MedPath