UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003632 |
|---|---|
| Receipt number | R000004244 |
| Scientific Title | Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable nonsquamous non-small cell lung cancer |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2015/11/18 14:44:20 |
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Basic information
Public title
Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable nonsquamous non-small cell lung cancer
Acronym
Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable
Scientific Title
Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable nonsquamous non-small cell lung cancer
Scientific Title:Acronym
Phase 1/2 trial of pemetrexed and cisplatin with concurrent thoracic radiation for stage III inoperable
Region
| Japan |
Condition
Condition
Non small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We planned to do phase I/II studies of pemetrexed and cisplatin with concurrent chemoradiotherapy. Our objectives are to define the maximum-tolerated dose and dose-limiting toxicity in the phase 1 study, and to determine the response rate, toxicity, and survival rate at the recommended dose in the phase 2 study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase 1:Dose Limiting Toxicity, Maximum Tolerated Dose
Phase 2:Response rate
Key secondary outcomes
Phase 1:Response rate
Phase 2:Toxicity, Median survival time
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 | Device,equipment |
Interventions/Control_1
Pemetrexed, Cisplatin, Radiotherapy
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Pathologically confirmed non-squamous non-small cell lung cancer
2)Unresectable stage 3A or3B
3)No previous treatment
4)An age of 20-70 years
5)ECOG performance status (PS) of 0 or 1
6)A life expectancy of 3 months or longer
7)Adequate organ function
8)Written informed consent
Key exclusion criteria
1)Active systemic infection
2)Pregnancy or lactation
3)Ascitic fluid or pleural effusion
4)Pericardial fluid retention
5)Peripheral neuropathy
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Iwasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
Address
465, Kawaramachi, Hirokoji Kamigyo-ku, Kyoto
TEL
075-251-5513
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Iwasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
Address
465, Kawaramachi, Hirokoji Kamigyo-ku, Kyoto
TEL
075-251-5513
Homepage URL
http://www.f.kpu-m.ac.jp/k/respir/
yiwasaki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
| 2010 | Year | 06 | 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
| 2010 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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 | 05 | Month | 18 | Day |
Last modified on
| 2015 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004244
| 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 |
