A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

Sponsor

Tomoshi Tsuchiya (Other)

Overall Status

Completed

CT.gov ID

NCT01459185

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: S-1	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S-1 Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer	Drug: 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) Other Names: Oral fluoropyrimidine S-1

Arm

Intervention/Treatment

Experimental: S-1

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

Drug: 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)

Other Names:

Oral fluoropyrimidine S-1

Outcome Measures

Primary Outcome Measures

Completion rate [One year]

Secondary Outcome Measures

Incidence and grade of adverse reactions [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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))

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences	Nagasaki		Japan	852-8501

Sponsors and Collaborators

Tomoshi Tsuchiya

Investigators

Study Chair: Takeshi Nagayasu, MD. PhD., Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences