UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004810 |
|---|---|
| Receipt number | R000005727 |
| Scientific Title | Phase I/II trial of pemetrexed + carboplatin followed by maintenance pemetrexed therapy in elderly patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2010/12/31 |
| Last modified on | 2016/11/24 21:52:57 |
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Basic information
Public title
Phase I/II trial of pemetrexed + carboplatin followed by maintenance pemetrexed therapy in elderly patients with advanced non-small cell lung cancer
Acronym
CBDCA+PEM followed by PEM in elderly patients (Phase I/II trial)
Scientific Title
Phase I/II trial of pemetrexed + carboplatin followed by maintenance pemetrexed therapy in elderly patients with advanced non-small cell lung cancer
Scientific Title:Acronym
CBDCA+PEM followed by PEM in elderly patients (Phase I/II trial)
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In phase I trial
safety of CBDCA + PEM followed by PEM in eldery patients with NSCLC
In phase II trial
efficacy of CBDCA + PEM followed by PEM in eldery patients with NSCLC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
In phase I trial
decision of maximum tolerated dose and recommended dose
In phase II trial
Key secondary outcomes
In phase II trial
safety,
efficacy (response rate)
Progression free Survival,
Overall survival
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
Calboplatin + pemetrexed
Maintenance pemetrexed therapy
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
non squamous cell non-small cell lung carcinoma,
advanced NSCLC,
PS 0-1,
good internal organs,
Case of whom living for three months or more from administering start date is expected,
Case who obtained agreement
Key exclusion criteria
1, squamou cell lung cancer
2, Interstitial change in chest X-ray or chest CT,
3, case of uncontrolled fluid
4, not medication of Vitanmin B12 and folic acid
5, Case who has serious renal dysfunction
6, Case of brain metastasis that has symptom
7, Case who has double cancer of briskness
8, case of uncontroled hypertension and diabetic
9, Case diagnosed as cirrhosis
10, Case who has cardiac illness
etc
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Kawase |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name
Thoracic Malignancy
Zip code
Address
3-7-1 Habikino Habikino city Osaka Prefectural
TEL
072-957-2121
moto19781205@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Tamiya |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name
Thoracic Malignancy
Zip code
Address
3-7-1 Habikino Habikino city Osaka Prefectural
TEL
0729572121
Homepage URL
moto19781205@yahoo.co.jp
Sponsor or person
Institute
1:Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
2:Kinki-Chuo chest medical center
Institute
Department
Personal name
Funding Source
Organization
1: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
2: Kinki-Chuo chest medical center
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
1:大阪府立呼吸器・アレルギー医療センター
2:近畿中央胸部疾患センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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 | 12 | Month | 30 | Day |
Last modified on
| 2016 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005727
