UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009003 |
|---|---|
| Receipt number | R000010521 |
| Scientific Title | Analysis of genetic polymorphism relating to interstitial lung disease events in with advanced pancreatic cancer patients receiving gemcitabine plus erlotinib |
| Date of disclosure of the study information | 2012/09/28 |
| Last modified on | 2018/10/03 16:04:06 |
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Basic information
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
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
| 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
hminami@med.kobe-u.ac.jp
Public contact
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
meinishi@hp.pref.hyogo.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010521
