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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006592
Receipt No. R000007795
Scientific Title A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer
Date of disclosure of the study information 2011/10/30
Last modified on 2015/10/22

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Basic information
Public title A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer
Acronym A feasibility study of oral adjuvant chemotherapy with S-1
Scientific Title A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer
Scientific Title:Acronym A feasibility study of oral adjuvant chemotherapy with S-1
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confrim feasibility of adjuvant chemotherapy with 1 year oral administration of S-1 for non-small cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Completion rate of scheduled adjuvant chemotherapy
Key secondary outcomes Incidence and grade of adverse reactions.
3-year and 5-year overall survivial.
3-year and 5-year relapse free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key 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))
Key exclusion criteria 1.History of drug hypersensitivity.
2.Contraindication of oral S-1 administration (refer appended papaer).
3.Serious surgical or non-surgical complications
4.Active secondary cancer.
5.Watery diarrea.
6.Pregnant or lactating women.
7.Male who has intension to make pregnant
8.Patient to whom primary doctor judjed inadequate to register.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nagayasu
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Division of Surgical Oncology
Zip code
Address 1-7-1 Sakamoto Nagasaki
TEL 095-819-7304
Email nagayasu@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoshi Tsuchiya
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Division of Surgical Oncology
Zip code
Address 1-7-1 Sakamoto Nagasaki
TEL 095-819-7304
Homepage URL
Email tomoshi@nagasaki-u.ac.jp

Sponsor
Institute Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長崎大学病院(長崎県)、佐世保総合病院(長崎県)、国立長崎医療センター(長崎県)、長崎原爆病院(長崎県)、大分県立病院(大分県)、長崎済生会病院(長崎県)、福田外科病院(長崎県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22424872
Number of participants that the trial has enrolled
Results
Results: Fifty patients were eligible. The completion rate for the planned 8 courses of S-1 administration was 72.0%
(36 patients). Total percentage administration amount was 71.1%. Grade 3 adverse reactions such as neutropenia
(4.0%), anorexia (4.0%), thrombopenia (2.0%), anemia (2.0%), elevated total bilirubin (2.0%), hypokalemia (2.0%),
nausea (2.0%), and diarrhea (2.0%) were observed, but no grade 4 adverse effects were encountered. Overall and
relapse-free survival rates at 3 years were 87.7% and 69.4%, respectively. Conclusions: Postoperative 1-year
administration of S-1 seems feasible as oral adjuvant chemotherapy for lung cancer. The oral formulation and low
incidence of adverse reactions permit treatment on an outpatient basis. The present study would be reasonable to
follow up with a properly powered phase III trial.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 22 Day
Last modified on
2015 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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