UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of adjuvant chemotherapy with gemcitabine and cisplatin for completely resected NSCLC
Title of the study (Brief title)	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	Makoto Suzuki
Organization	Kumamoto University Hospital
Division name	Department of Thoracic Surgery
Address	1-1-1 Honjo,Kumamoto
TEL	096-373-5533
Email	smakoto@kumamoto-u.ac.jp

Public contact
Name of contact person	Makoto Suzuki
Organization	Kumamoto University Hospital
Division name	Department of Thoracic Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006252