UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006355 |
|---|---|
| Receipt number | R000007537 |
| Scientific Title | Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Relapsed Non-squamous and Non-small Cell Lung Cancer |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2014/12/11 15:10:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Relapsed Non-squamous and Non-small Cell Lung Cancer
Acronym
Pemetrexed monotherapy for PS2 patients with Non-sq NSCLC
Scientific Title
Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Relapsed Non-squamous and Non-small Cell Lung Cancer
Scientific Title:Acronym
Pemetrexed monotherapy for PS2 patients with Non-sq NSCLC
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of pemetrexed monotherapy for performance status 2 pretreated patients with metastatic 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
Overall survival
Key secondary outcomes
Response rate
Progression-free 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 at a dose of 500 mg/m2 every 3 weeks is administered until progression disease.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
(except 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 1 or 2 prior chemoterapy
3)With measurable or inmeasurable 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 weeks
5)over 20 years old
6)ECOG PS 2
7)History of 1 or 2 prior chemotherapy (EGFR-TKIs and UFT can be uncountable)
8)In patients with sensitive EGFR mutations, they become eligible after failure of EGFR-TKIs.
9)Adequate organ function
10)Life expectancy more than 3 months
11)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
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Integrated Oncology
Zip code
Address
2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akito Hata |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Integrated Oncology
Zip code
Address
2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL
Homepage URL
a-hata@fbri.org
Sponsor or person
Institute
Hanshin 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
神戸市立医療センター 中央市民病院
神戸大学医学部付属病院 呼吸器内科
先端医療センター 総合腫瘍科
兵庫県立がんセンター 呼吸器内科
大阪府立成人病センター 呼吸器内科
刀根山病院 呼吸器内科
倉敷中央病院 呼吸器内科
桂病院 呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 15 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007537
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
