UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025062 |
|---|---|
| Receipt number | R000028734 |
| Scientific Title | Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2019/03/29 11:22:09 |
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Basic information
Public title
Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Acronym
Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Scientific Title
Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Scientific Title:Acronym
Pemetrexed monotherapy in chemo-naive elderly patients with advanced non-squamous non-small cell lung cancer.
Region
| Japan |
Condition
Condition
Non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of PEM monotherapy for elderly patients in advanced non-squamous non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Safety, Response rate, Rate of treatment completion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with pemetrexed (500mg/m2)
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
1. Pathologically or cytologically diagnosed stage IIIB, stage IV or recurrence non-squamous non-small cell lung cancer
2. Without receiving cytotoxic agents chemotherapy
3. ECOG PS of 0-1
4. Life expectancy of more than 12 weekss
5. Adequate organ function
Neutrophil cout of more than 1,500/mm3
Platelet cout of more than 100,000/mm3
Aspartate transaminase (AST), alanine transaminase(ALT): less than 100IU/L
Total bilirubin: less than 1.5mg/dL
Serum creatinine of less than 1.5mg/dL or creatinine clearance of less than 45mL/min
Key exclusion criteria
1. Superior vena cava syndrome
2. History of severe hypersensitivity to drugs
3. Uncontrolled pleural effusion, peritoneal effusion, and cardiac effusion
4. Severe infectious disease or severe uncontrolled complication
5. Interstitial lung disease or pulmonary fibrosis
6. Active malignancy of other organ
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Kaneda |
Organization
Kurashiki Central Hospital
Division name
Department of respiratory medicine
Zip code
Address
1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL
086-422-0210
tk15127@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Kaneda |
Organization
Kurashiki Central Hospital
Division name
Department of respiratory medicine
Zip code
Address
1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL
086-422-0210
Homepage URL
tk15127@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
公益財団法人大原記念倉敷中央医療機構 倉敷中央病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | 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
| 2016 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028734
