UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of genetic polymorphism relating to interstitial lung disease events in with advanced pancreatic cancer patients receiving gemcitabine plus erlotinib
Title of the study (Brief title)	Analysis of genetic polymorphism relating to interstitial lung disease events in with advanced pancreatic cancer patients receiving gemcitabine plus erlotinib
Region	Japan

Condition
Condition	advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Analyse genetic polymorphism relating interstitial lung disease events in advanced pancreatic cancer patients receiving gemcitabine plus erlotinib.
Basic objectives2	Others
Basic objectives -Others	assesment of overall survival and progression free survival,validity,toxicity in advanced pancreatic cancer patients receiving gemcitabine plus erlotinib.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	genetic polymorphism relating interstitial lung disease events in patients receiving gemcitabine plus erlotinib
Key secondary outcomes	overall survival and progression free survival,validity,toxicity inpatients receiving gemcitabine plus erlotinib

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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)Patinents with histological or cytological evidence of pancreactic cancer(exclude of neuroendocrine tumor). Or,cytology is class 4,but clinically diagnosed pancreactic cancer. 2)Unresectable locally advanced or metastatic pancreatic cancer. 3)Patients aged more than 20 and less than 80. 4)Eastern Cooperative Oncology Group performance status of 0,1 5)That's ok there is not measurable lesion. 6)If patients who had a history of the following medications, more than 2 weeks have passed. chemotherapy:the last receiving day radiation:tha last radiation day. (We exclude radiation to the chest.) operation:tha last receiving day.(We exclude percutaneous transhepatic cholangio drainage.) 7)Patiens who have adequate hematological,renal and respiratory, heart function. a)Neutrophil count is more than 1500/mm3. b)Hemoglobin is more than 9.0g/dl c)Platlet is more than 100000/mm3 d)ALT/AST is less than 2.5 times upper limits of normal.In case of drainage of obstructive jaundice,less than 5 times upper limits of normal. e)T-Bil is less than 2.0mg/dl. f)sCr is less than 1.5 times upper limits of normal. 8)There is no interstitial lung disease on chest plain CT within 4 weeks. 9)Patients who have a life expectancy of at least 2 months. 10)Patinets who can hospitalization at least 4 weeks. 11)Informed consent can obtain from patients.
Key exclusion criteria	1)Pregnancy,lactational woman.Man hope who's partner's pregnancy. 2)Patients who have a concurrent or previous interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis,drug-induced pneumonia. 3)Patients who have a concurrent or previous pulmonary emphysema or chronic obstructive pulmonary disease. 4)Patients who are after resection one lung. 5)Patients who have a history of radiation to the chest. 6)Patients who have received gemcitabine within 3 months. 7)Patients who had previously been exposed to EGFR inhibitor. 8)Patients who received transfusion within 4 weeks before registry. 9)Patients who have the follows digestive tract damage. patients who can't take a pill. patients wfo have active ulcer. 10)Patients who have clinically problematical oculus disease(serious xerosis,keratoconjunctivitis sicca, keratitis). 11)Patients who have symptomatic metastatic brain tumor. 12)Patients who have active bacterium or fungus infections. 13)Patients who have a concurrent clinically problematical heart disease(uncontroled hypertension,unstable angina, congestive heart failure,severe arrhythmia,myocarcial infraction within 12 months before registry). 14)Patients who have a current uncontroled diabetes mellitus. 15)Patients who have massive humor pool or edema. 16)Patiens who have previous severe drug-induced allergy. 17)In cases of doctor judged inappropriate for this protocol.
Target sample size	50

Research contact person
Name of lead principal investigator	Hironobu Minami
Organization	Kobe University Hospital
Division name	Department of Medical Oncology and Hematology
Address	7-5-2, Kusunokicho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-5111
Email	hminami@med.kobe-u.ac.jp

Public contact
Name of contact person	Meiko Nishimura
Organization	Kobe University Hospital
Division name	Department of Medical Oncology and Hematology
Address	7-5-2, Kusunokicho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-5111
Homepage URL
Email	meinishi@hp.pref.hyogo.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	Kobe University Hospital
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	2012 Year 09 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 26 Day
Anticipated trial start date	2012 Year 12 Month 26 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	Published
URL releasing results
Results	The combination of HLA-B*15:01 and DRB1*15:01 suggested to be associated with ILD in Japanese patients with advanced pancreatic cancer receiving gemcitabine plus erlotinib.
Other related information	prospective study. we get serum from patients and analysis of genetic polymorphism relating to interstitial lung disease events. we also observe progression free survival,overall survival,validity and toxicity.

Management information
Registered date	2012 Year 09 Month 28 Day
Last modified on	2018 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010521