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A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer

Phase 2
20 Years
79 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer

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 surface area (BSA): BSA <1.25 m2, 80 mg/day; BSA >1.25 m2 but <1.5 m2, 100
mg/day; and BSA >1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals,
starting within 4 weeks after surgery.

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 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Completion rate

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Takeshi Nagayasu, MD. PhD.

Investigator Role:

Study Chair

Investigator Affiliation:

Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences


Japan: Institutional Review Board

Study ID:




Start Date:

June 2005

Completion Date:

March 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Adjuvant chemotherapy
  • oral fluoropyrimidine
  • S-1
  • Feasibility study
  • Surgery
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms