A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

Tomoshi Tsuchiya55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

S-1DRUG

Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal; total 1 year) of S-1 at 80-120 mg/body/day according to body surface area (BSA)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (1)

Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences

Nagasaki, Nagasaki, Japan

Outcomes

Primary Outcomes

Completion rate

Time frame: One year

Secondary Outcomes

Incidence and grade of adverse reactions

Time frame: One year

Data from ClinicalTrials.gov

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