A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

September 23, 2014 updated by: Tomoshi Tsuchiya

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagasaki, Japan, 852-8501
        • Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion rate
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and grade of adverse reactions
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R000007795

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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