A Feasibility Study of Oral Adjuvant Chemotherapy With S-1
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Start date||June 2005|
|End date||May 2008|
|Trial size||55 participants|
|Trial identifier||NCT01459185, R000007795|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: One year
Incidence and grade of adverse reactions
time frame: One year
Male or female participants from 20 years up to 79 years old.
- NSCLC with histological proof.
- Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection.
- No prior treatment except for surgery.
- Sufficient oral intake.
- Performance status (PS) 0 or 1.
- 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))
- History of drug hypersensitivity.
- Contraindication of oral S-1 administration (refer appended paper).
- Serious surgical or non-surgical complications
- Active secondary cancer.
- Watery diarrhea.
- Pregnant or lactating women.
- Male who has intention to make pregnant
- Patient to whom primary doctor judged inadequate to register.
|Official title||A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer|
|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.|
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