Back to resultsA Feasibility Study of Oral Adjuvant Chemotherapy With S-1
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
S-1
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, Adjuvant chemotherapy, oral fluoropyrimidine, S-1, Feasibility study, Surgery
Eligibility Criteria
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.
Sites / Locations
- Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-1
Arm Description
Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer
Outcomes
Primary Outcome Measures
Completion rate
Secondary Outcome Measures
Incidence and grade of adverse reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01459185
Brief Title
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1
Official Title
A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tomoshi Tsuchiya
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small cell lung cancer, Adjuvant chemotherapy, oral fluoropyrimidine, S-1, Feasibility study, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-1
Arm Type
Experimental
Arm Description
Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
Oral fluoropyrimidine S-1
Intervention Description
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)
Primary Outcome Measure Information:
Title
Completion rate
Time Frame
One year
Secondary Outcome Measure Information:
Title
Incidence and grade of adverse reactions
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Nagayasu, MD. PhD.
Organizational Affiliation
Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1
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