Status:
COMPLETED
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1
Lead Sponsor:
Tomoshi Tsuchiya
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
Brief Summary
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 cance...
Detailed Description
Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT, gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day according to body s...
Eligibility Criteria
Inclusion
- NSCLC with histological proof.
- Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection.
- No prior treatment except for surgery.
- Sufficient oral intake.
- Performance status (PS) 0 or 1.
- 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
- History of drug hypersensitivity.
- Contraindication of oral S-1 administration (refer appended paper).
- Serious surgical or non-surgical complications
- Active secondary cancer.
- Watery diarrhea.
- Pregnant or lactating women.
- Male who has intention to make pregnant
- Patient to whom primary doctor judged inadequate to register.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01459185
Start Date
June 1 2005
End Date
March 1 2012
Last Update
September 25 2014
Active Locations (1)
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1
Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences
Nagasaki, Nagasaki, Japan, 852-8501