Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker

Phase 2

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-UMIN000009872
• Lead Sponsor: Department of Respiratory Medicine National Center for Global health and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-31
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

1)History of allergic reaction for agents of present treatment 2)Severe myelosupperssion, renal dysfunction or hepatic dysfunction 3)Patients received post-operation adjuvant therapy within 6 months. 4)Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free 5)Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease 6)Diarrhea more than and equal to grade 2 7)Active infection more than and equal to grade 2 8)Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 9)Symptomatic brain metastasis but eligible for controlled brain metastases 10)Patients required for continuing steroid therapy 11)Pregnant status or lactation 12)Uncontrolled psychiatric disease 13)Other ineligible status judged by medical oncologist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified