UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC
Title of the study (Brief title)	Feasibility study of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC
Region	Japan

Condition
Condition	Completely resected NSCLC(non-squamous cell carcinoma, stage II - IIIA)
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 cisplatin and pemetrexed short hydration regimen for completely resected NSCLC (non-squamaous cell carcinoma) with staged II to IIIA.
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	1.safety 2.extraction rate from hospitalization to outpatient clinic 3.2-years disease free survival

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	Dose:day1 CDDP 75mg/m2+PEM 500 mg/m2 with short hydration 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	75 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 II - IIIA that received segmentectomy, lobectomy, or bi-lobectomy (3) Performance Status is 0 - 1 (ECOG). (4) 20 years of age or older, 75 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 - 8 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 uncontrolled pleural effuson (6)The patient with a motor-palsy or figure of peripheral-nerve-disease (7)The patient with drug hypersensitivity (8)The patient with common use of NSAIDs (9)The expectant mother, the woman who has a lactating-woman and the possibility of the pregnancy (10)The patient judged as unsuitable by the doctor
Target sample size	21

Research contact person
Name of lead principal investigator	Motoko Tachihara
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine,
Address	7-5-1, Kusunoki-Cho,Chuo-Ku, Kobe
TEL	078-382-5846
Email	mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person	Motoko Tachihara
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine,
Address	7-5-1, Kusunoki-Cho,Chuo-Ku, Kobe
TEL	078-382-5846
Homepage URL
Email	mt0318@med.kobe-u.ac.jp

Sponsor
Institute	Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 13 Day
Anticipated trial start date	2013 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	2013 Year 03 Month 28 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012100