Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment s-1
Phase phase 2
Sponsor Tomoshi Tsuchiya
Start date June 2005
End date May 2008
Trial size 55 participants
Trial identifier NCT01459185, R000007795

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer
s-1 Oral fluoropyrimidine S-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)

Primary Outcomes

Measure
Completion rate
time frame: One year

Secondary Outcomes

Measure
Incidence and grade of adverse reactions
time frame: One year

Eligibility Criteria

Male or female participants from 20 years up to 79 years old.

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 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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Nagasaki University.