Non-small Cell Lung Cancer Clinical Trial
Official title:
A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer
Verified date | September 2014 |
Source | Nagasaki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Interventional |
The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small cell lung cancer. The investigators presume they can achieve high completion rate with low toxicity.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 2012 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 79 Years |
Eligibility |
Inclusion Criteria: 1. NSCLC with histological proof. 2. Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection. 3. No prior treatment except for surgery. 4. Sufficient oral intake. 5. Performance status (PS) 0 or 1. 6. Patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; AST and ALT, less than twice the normal limits at each institution; BUN, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (Ccr)) Exclusion Criteria: 1. History of drug hypersensitivity. 2. Contraindication of oral S-1 administration (refer appended paper). 3. Serious surgical or non-surgical complications 4. Active secondary cancer. 5. Watery diarrhea. 6. Pregnant or lactating women. 7. Male who has intention to make pregnant 8. Patient to whom primary doctor judged inadequate to register. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences | Nagasaki |
Lead Sponsor | Collaborator |
---|---|
Tomoshi Tsuchiya |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion rate | One year | Yes | |
Secondary | Incidence and grade of adverse reactions | One year | Yes |
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