Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer.
- Conditions
- lung cancer
- Registration Number
- JPRN-UMIN000011210
- Lead Sponsor
- Teikyo University school of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Cases in which apparent interstitial pneumonia or pulmonary fibrosis is observed by routine chest radiograph or chest CT. 2) Cases which require drainage of accumulated pleural fluid, ascetic fluid and effusion. 3) Cases with synchronous or metachronous active double cancer or multiple cancer. 4) Cases with complications which are hard to control (such as cardiac disease, liver disease, severe diabetes and hemorrhage). 5) Cases accompanied with diarrhea (watery diarrhea). 6) Patients who are pregnant or nursing or women who might be pregnant. 7) Male patients planning to have a child. 8) Patients with prior drug hypersenstitivity. 9) Patients with history of severe hypersensitivity to TS-1 components. 10) Patients who are undergoing a treatment with other fluorinated pyrimidine-type anti-tumor drugs. 11) Patients in which the administration of TS-1 is prohibited. 12) Patients who are undergoing a treatment with warfarin potassium, phenytoin or flucytosine. 13) Other cases which are determined to be unsuitable to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment completion rate
- Secondary Outcome Measures
Name Time Method Overall survival period (OS), Recurrence free survival period (RFS), Adverse effect occurrence rate, recurrence pattern