UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005552 |
|---|---|
| Receipt number | R000006470 |
| Scientific Title | A Phase 2 study of pemetrexed and carboplatin for platinum-pretreated patients with non small cell lung cancer |
| Date of disclosure of the study information | 2011/05/04 |
| Last modified on | 2013/09/05 18:14:40 |
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Basic information
Public title
A Phase 2 study of pemetrexed and carboplatin for platinum-pretreated patients with non small cell lung cancer
Acronym
A Phase 2 study of PEM and CBDCA for platinum-pretreated patients with lung cancer
Scientific Title
A Phase 2 study of pemetrexed and carboplatin for platinum-pretreated patients with non small cell lung cancer
Scientific Title:Acronym
A Phase 2 study of PEM and CBDCA for platinum-pretreated patients with lung cancer
Region
| Japan |
Condition
Condition
platinum pretreated patients with non small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
effective
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
efficacy
Key secondary outcomes
safety,OS,PFS
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/mm over a 10 minutes intravaenous infusion and carboplatin at an AUC 5mg/mL/min over a 30 minutes intravenous infusion on Day1 of a 21 day cycle.
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 confirmed non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent)
2) Stage III/IV of platinum pretreated patients
3) Patients aged 20 years or older
4) Karnofsky performance status 0-1
5) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST
6) Adequate organ function
7) Excepted to live over 3 months after administration day
8) Written informed consent from the patients
Key exclusion criteria
Exclusion criterias are as follows
1: Active interstitial pneumonia identified by chest X-ray
2: Uncontrolled massive pleural effusion or cardiac effusion
3: Superior vena cava syndrome
4: Uncontrolled brain metastases
5: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 12 months
6: Severe infection
7: Pregnancy or lactation
8: Active concomitant malignancy
9: History of severe allergic reactions to drugs
11: Severe and unstable medical 10morbidities
11: Judgment to attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Hirashima |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic deseases
Division name
Thoracic Malignancy
Zip code
Address
Osaka Prefecture Habikino city Habikino 3-7-1
TEL
072-957-2121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Tamiya |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic deseases
Division name
Thoracic Malignancy
Zip code
Address
TEL
072-957-2121
Homepage URL
moto19781205@yahoo.co.jp
Sponsor or person
Institute
Osaka Prefectural Medical Center for Respiratory and Allergic deseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic deseases
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
| 2011 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 15 | 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
| 2011 | Year | 05 | Month | 03 | Day |
Last modified on
| 2013 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006470
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
