Clinical trial · Interventional
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
NCT01459185CI-TRIAL-00015693completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1
- description
- Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer
- interventionNames
- Drug: S-1
Primary outcomes (1)
- measure
- Completion rate
- timeFrame
- One year
Secondary outcomes (1)
- measure
- Incidence and grade of adverse reactions
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.