A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

NCT ID: NCT01459185

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2012-03-31

Brief 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.

Detailed 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1

Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer

Group Type: EXPERIMENTAL

S-1

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Oral fluoropyrimidine S-1

Eligibility 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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomoshi Tsuchiya

OTHER

Sponsor Role: lead

Responsible Party

Tomoshi Tsuchiya

Senior Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Takeshi Nagayasu, MD. PhD.

Role: STUDY_CHAIR

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

Locations

Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences

Nagasaki, Nagasaki, Japan

Countries

Japan

Other Identifiers

R000007795

Identifier Type: -

Identifier Source: org_study_id