UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002468 |
|---|---|
| Receipt number | R000003006 |
| Scientific Title | A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2009/09/09 |
| Last modified on | 2013/02/27 18:54:54 |
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Basic information
Public title
A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Acronym
A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title
A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym
A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
Elderly patients with previously untreated non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of pemetrexed for elderly patients with previously untreated non-squamous non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival
Overall survival
Disease control rate
Safety
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
Pemetrexed(500mg/m2) day 1,q3w until disease progression
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
(without large cell neuroendocrine carcinoma)
2)Non-squamous non-small cell cancer patients with stage IIIB(with pleural dissemination or malignant pleural effusion),stage IV or recurrent disease after surgery,who have no prior chemoterapy
3)With measurable lesion
4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration
i)Radiotherapy including pulmonary field ->3 months
ii)Radiotherapy other than thoracic radiation ->1 month
5)75 years or older
6)ECOG PS 0-1
7)Adequate organ function
8)Life expectancy more than 3 months
9)Written informed consent
Key exclusion criteria
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of active infection or other serious disease condition
(GI bleeding,etc.)
5)History of poorly controlled pleural effusion,pericardial effusion and ascites
6)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.)
7)Uncontrollable diabetes mellitus
8)History of symptomatic brain metastases
9)Hystory of active double cancer
10)History of active psychological disease
11)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kotani |
Organization
Kobe University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5846
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiiro Hattori |
Organization
Hyogo Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
TEL
078-929-1151
Homepage URL
hattori@hp.pref.hyogo.jp
Sponsor or person
Institute
Kobe Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
神戸大学医学部附属病院（兵庫県）
先端医療センター（兵庫県）
兵庫県立がんセンター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2009 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 07 | Day |
Last modified on
| 2013 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003006
