UMIN-CTR Clinical Trial

Public title

Analysis of genetic polymorphism relating to interstitial lung disease events in with advanced pancreatic cancer patients receiving gemcitabine plus erlotinib

Acronym

Analysis of genetic polymorphism relating to interstitial lung disease events in with advanced pancreatic cancer patients receiving gemcitabine plus erlotinib

Scientific Title

Analysis of genetic polymorphism relating to interstitial lung disease events in with advanced pancreatic cancer patients receiving gemcitabine plus erlotinib

Scientific Title:Acronym

Analysis of genetic polymorphism relating to interstitial lung disease events in with advanced pancreatic cancer patients receiving gemcitabine plus erlotinib

Region

Japan

Condition

advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hironobu Minami

Organization

Kobe University Hospital

Division name

Department of Medical Oncology and Hematology

Zip code

Address

7-5-2, Kusunokicho, Chuo-ku, Kobe, Hyogo, Japan

TEL

078-382-5111

Email

hminami@med.kobe-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Meiko Nishimura

Organization

Kobe University Hospital

Division name

Department of Medical Oncology and Hematology

Zip code

Address

7-5-2, Kusunokicho, Chuo-ku, Kobe, Hyogo, Japan

TEL

078-382-5111

Homepage URL

Email

meinishi@hp.pref.hyogo.jp

Institute

Kobe University Hospital

Institute

Department

Personal name

Organization

Kobe University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

09

Month

28

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

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.

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

12

Month

26

Day

Date of IRB

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

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.

Registered date

2012

Year

09

Month

28

Day

Last modified on

2018

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010521