A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Nagasaki University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Tomoshi Tsuchiya, Nagasaki University
ClinicalTrials.gov Identifier:
NCT01459185
First received: October 21, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: S-1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Nagasaki University:

Primary Outcome Measures:
  • Completion rate [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and grade of adverse reactions [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: June 2005
Estimated Study Completion Date: March 2012
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oral fluoropyrimidine S-1

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01459185

Locations
Japan
Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences
1-7-1 Sakamoto 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
  More Information

No publications provided

Responsible Party: Tomoshi Tsuchiya, Senior Assistant Professor, Nagasaki University
ClinicalTrials.gov Identifier: NCT01459185     History of Changes
Other Study ID Numbers: R000007795
Study First Received: October 21, 2011
Last Updated: October 24, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Nagasaki University:
Non-small cell lung cancer
Adjuvant chemotherapy
oral fluoropyrimidine
S-1
Feasibility study
Surgery

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014