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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005256
Receipt No. R000006252
Scientific Title Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Date of disclosure of the study information 2011/03/17
Last modified on 2017/03/21

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Basic information
Public title Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Acronym Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Scientific Title Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Scientific Title:Acronym Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Region
Japan

Condition
Condition Completely resected NSCLC (stage IB - IIIA including multiple N2)
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate feasibility of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC (segmentectomy, lobectomy or bi-lobectomy) with staged IB to IIIA including pN2.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Chemotherapy compliance in the four cycles
Key secondary outcomes

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 Period: From March 2011 to Febrary 2013
Dose:GEM 1000mg/m2 d1.d8+CDDP 80mg/m2 d1
Cycle: 4 cycles
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)The patient histologically proven as non-small cell lung cancer
(2)The patient with p-staged IB - IIIA that received segmentectomy, lobectomy, or bi-lobectomy (including multiple pN2)
(3) Performance Status is 0 - 1 (ECOG).
(4) 20 years of age or older, 80 years of age or younger.
(5) The patient who does not receive any chemotherapy, radiotherapy, or immunotherapy prior to resection
(6) The patient who preserves the main organ ( the bone marrow, liver, kidney and so on )
(7) The patient who can receive chemotherapy within 4 - 12 weeks after resection
(8) The patient who gives written informed consent
Key exclusion criteria (1)The patient with infection
(2)The patient with fever (equal to or more than 38 C)
(3)The patient with heavy complication
(4)The patient with active double-cancer
(5)The patient with chickenpox
(6)The patient with a motor-palsy or figure of peripheral-nerve-disease
(7)The patient with drug hypersensitivity
(8)The expectant mother, the woman who has a lactating-woman and the possibility of the pregnancy
(9)The patient judged as unsuitable by the doctor
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Suzuki
Organization Kumamoto University Hospital
Division name Department of Thoracic Surgery
Zip code
Address 1-1-1 Honjo,Kumamoto
TEL 096-373-5533
Email smakoto@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Suzuki
Organization Kumamoto University Hospital
Division name Department of Thoracic Surgery
Zip code
Address Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL 096-373-5533
Homepage URL
Email smakoto@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 17 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
2011 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 16 Day
Last modified on
2017 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006252

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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