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

October 21, 2011
October 24, 2011
June 2005
May 2008   (final data collection date for primary outcome measure)
Completion rate [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01459185 on ClinicalTrials.gov Archive Site
Incidence and grade of adverse reactions [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: S-1
Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer
Intervention: Drug: S-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
55
March 2012
May 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01459185
R000007795
No
Tomoshi Tsuchiya, Nagasaki University
Tomoshi Tsuchiya
Not Provided
Study Chair: Takeshi Nagayasu, MD. PhD. Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Nagasaki University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP