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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005552
Receipt No. 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

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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
Email

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
Email moto19781205@yahoo.co.jp

Sponsor
Institute Osaka Prefectural Medical Center for Respiratory and Allergic deseases
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006470

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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