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A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer

A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer - A feasibility study of oral adjuvant chemotherapy with S-1

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006592
Enrollment
55
Registered
2011-10-30
Start date
2005-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Interventions

S-1

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1.History of drug hypersensitivity. 2.Contraindication of oral S-1 administration (refer appended papaer). 3.Serious surgical or non-surgical complications 4.Active secondary cancer. 5.Watery diarrea. 6.Pregnant or lactating women. 7.Male who has intension to make pregnant 8.Patient to whom primary doctor judjed inadequate to register.

Design outcomes

Primary

MeasureTime frame
Completion rate of scheduled adjuvant chemotherapy

Secondary

MeasureTime frame
Incidence and grade of adverse reactions. 3-year and 5-year overall survivial. 3-year and 5-year relapse free survival

Countries

Japan

Contacts

Public ContactTomoshi Tsuchiya

Nagasaki University Graduate School of Biomedical Sciences Division of Surgical Oncology

tomoshi@nagasaki-u.ac.jp095-819-7304

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026