UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004018 |
|---|---|
| Receipt number | R000004830 |
| Scientific Title | Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients |
| Date of disclosure of the study information | 2010/08/10 |
| Last modified on | 2010/08/09 13:38:08 |
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Basic information
Public title
Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Acronym
Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Scientific Title
Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Scientific Title:Acronym
Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Region
| Japan |
Condition
Condition
Non-squamous non-small cell lung cancer in elderly chemo-naive patients
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of pemetrexed for chemo-naive non-squamous non-small cell lung cancer in elderly patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival
Progression free survival
Safety
Quality of life
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
| 70 | 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
2)Chemo-naive clinical stage IIIB/IV or relapsed patients (no indication of surgery or radiotherapy)
3)Age of 70 years or older
4)Performance status(PS) of 0-1 in ECOG criteria
5)Adequate organ functions
6)With measurable lesion
7)Life expectancy more than 3 months
8)Written informed consent
Key exclusion criteria
1)Patients with brain metastasis in need of steroid or anticonvulsant
2)Previous radiation therapy to primary lesion
3)History of active double cancer
4)Patients with superior vena cava syndrome
5)Uncontrollable pleural effusion, pericardial effusion or ascites
6)History of uncontrollable hypertention, diabetes mellitus, active angina pectoris, active gastrointestinal hemorrhage, recent cardiac incompetence, recent myocardial infarction, and active virus infection(except viral hepatitis)
7)Interstitial pneumonia or pulmonary fibrosis obviously detectable on chest X-ray
8)History of severe drug allergy
9)History of severe psychiatric disease
10)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takahashi |
Organization
Juntendo University, School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Hongo,Bunkyo-Ku,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Muraki |
Organization
Juntendo University, School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Hongo,Bunkyo-Ku,Tokyo
TEL
03-5802-1063
Homepage URL
Sponsor or person
Institute
Juntendo University
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 09 | Day |
Last modified on
| 2010 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004830
