UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006113 |
|---|---|
| Receipt number | R000005050 |
| Scientific Title | A Phase II Study of Pemetrexed in chemo-naive Elderly Patients with Lung Adenocarcinoma and An exploratory study on Mechanisms of chemotherapy resistance. |
| Date of disclosure of the study information | 2011/08/04 |
| Last modified on | 2013/08/03 16:19:12 |
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Basic information
Public title
A Phase II Study of Pemetrexed in chemo-naive Elderly Patients with Lung Adenocarcinoma and An exploratory study on Mechanisms of chemotherapy resistance.
Acronym
A Phase II Study of Pemetrexed in chemo-naive Elderly Patients with Lung Adenocarcinoma and An exploratory study on Mechanisms of chemotherapy resistance.
Scientific Title
A Phase II Study of Pemetrexed in chemo-naive Elderly Patients with Lung Adenocarcinoma and An exploratory study on Mechanisms of chemotherapy resistance.
Scientific Title:Acronym
A Phase II Study of Pemetrexed in chemo-naive Elderly Patients with Lung Adenocarcinoma and An exploratory study on Mechanisms of chemotherapy resistance.
Region
| Japan |
Condition
Condition
Previously untreated lung adenocarcinoma
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 lung adenocarcinoma, and to explore mechanism of resistance for pemetrexed in pathological aspect..
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
one year survival rate
Key secondary outcomes
overall survival, progression-free survival, objective response rate, adverse effects.
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,q3~5w 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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically or cytologically proven lung adenocarcinoma
2. No indication for platinum doublet therapy
3. With measurable lesion based on RECIST
4. Previously untreated
5. ECOG PS 0-2
6. 70 years or older
7. Adequate organ function
8. Eligible in case of controlled pleural effusion
9)Eligible in case of controlled brain metastases
10)Written informed consent
Key exclusion criteria
1. Symptomatic brain metastasis
2. Massive pleural effusion
3. Hystory of active double cancer
4. History of uncontrollable diabetes mellitus, active angina pectoris, recent myocardial infaction, and severe complications
5. History of active infection
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Kuwano |
Organization
Jikei University Hospital
Division name
Division of Respirology, department of internal medicine
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo, 105-8461
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Seki |
Organization
Jikei University Daisan-Hospital
Division name
Division of Respirology, department of internal medicine
Zip code
Address
4-11-1, Izumi-honcho, Komae-shi, Tokyo, 201-8601 Japan
TEL
03-3480-1151
Homepage URL
ms97-seki@jikei.ac.jp
Sponsor or person
Institute
Division of Respirology, department of internal medicine, Jikei University Hospital
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
東京慈恵会医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2010 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 03 | Day |
Last modified on
| 2013 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005050
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