Overview

A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

Status:
Completed

Trial end date:
2012-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Tomoshi Tsuchiya

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 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.