A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459185
• Other study ID #: R000007795
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2011
• Last updated: September 23, 2014
• Start date: June 2005
• Est. completion date: March 2012

Study information

• Verified date: September 2014
• Source: Nagasaki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2012
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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)

Locations

Country	Name	City	State
Japan	Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Tomoshi Tsuchiya

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate		One year	Yes
Secondary	Incidence and grade of adverse reactions		One year	Yes