A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01459185

Enrollment

Registered

2011-10-25

Start date

2005-06-30

Completion date

2012-03-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer, Adjuvant chemotherapy, oral fluoropyrimidine, S-1, Feasibility study, Surgery

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 cancer. The investigators presume they can achieve high completion rate with low toxicity.

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 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.

Interventions

DRUGS-1

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Completion rate	One year

Secondary

Measure	Time frame
Incidence and grade of adverse reactions	One year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026