A randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer

Not Applicable

• Conditions: on-small-cell lung cancer

• Registration Number: JPRN-UMIN000027435
• Lead Sponsor: Clinical Research Support Center Kyushu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-22
• Study Completion: 2020-11-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free period. However, the lesions correspondent to carcinoma in situ of uterine cervix curable by topical treatment, resectable gastric cancer/colorectal cancer by endoscope and topically resectable skin cancer other than malignant melanoma are excluded from active double cancer). 2)Patients with anamnesis of drug-induced hypersensitivity. 3)Patients with severe postoperative complications (such as postoperative infection, rapture suture). 4)Patients with severe complications (such as diarrhoea, intestinal paralysis, ileus, uncontrollable diabetes mellitus, heart failure, kidney failure, liver failure). 5)Patients with interstitial pattern recognized as apparent interstitial pneumonia in chest CT. 6)Patients with active infection. 7)Female patients with pregnant or possibly pregnant (will), or nursing. 8)Patients under treatment of type of fluorinated pyrimidine antineoplastic. 9)Patients under treatment of flucytosine. 10)Any other patients who are regarded as unsuitable for this study by the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two year relapse free survival

Secondary Outcome Measures

Name	Time	Method
Treatment completion rate, incidence of adverse event, relative dose density, 2 year overall survival, 5 year overall survival, 2 year relapse free survival, 5 year relapse free survival, productivity of the work and activity disorder, quality of adjusted life year (QALY) converted from EQ-5D-5L.