UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002383
Receipt No. R000002925
Scientific Title Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Date of disclosure of the study information 2009/08/25
Last modified on 2013/03/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Acronym Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Scientific Title Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Scientific Title:Acronym Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Region
Japan

Condition
Condition non-small-cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Surgery in general Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Feasibility study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage of patients who accomplished S-1 therapy of eight courses.
Key secondary outcomes Adverse events
The relative total administration dose of S-1

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adjuvant chemotherapy of eight courses
(2-week administration and 1-week withdrawal): S-1 dose of 67mg/m2 twice daily
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically confirmed NSCLC
2)p-Stage IB, II and III & complete resection
3)No prior treatment
4)Adjuvant chemotherapy within 4-8 weeks
5)ECOG PS 0-1
6)Age 70 or older
7)Adequate organ function
8)Written informed consent
Key exclusion criteria 1)Past history of drug hypersensitivity
2)Past history of myocardial infarction within 6 months
3)Interstitial pneumonia or active lung fibrosis
4)Uncontrolled heart diseases
5)Uncontrolled psychiatric disorders
6)Uncontrolled diabetes
7)Bowel problems
8)Active infection
9)Severe complications
10)Active concomitant malignancy
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukito Ichinose
Organization National Kyushu Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address Fukuoka
TEL 092-541-3231
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Ebi
Organization Iizuka Hospital
Division name Department of respiratory medicine
Zip code
Address
TEL 0948-22-3800
Homepage URL
Email

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center kyushu
Organization
Division
Category of Funding Organization Non profit foundation
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 飯塚病院(福岡県)、新日鐵八幡記念病院(福岡県)、大分県立病院(大分県)、熊本地域医療センター(熊本県)、長崎大学病院(長崎県)、浜の町病院(福岡県)、国立病院機構大牟田病院(福岡県)、九州大学(福岡県)、熊本大学(熊本県)

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2009 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 25 Day
Last modified on
2013 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.