UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011325 |
|---|---|
| Receipt number | R000012988 |
| Scientific Title | Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia |
| Date of disclosure of the study information | 2013/07/31 |
| Last modified on | 2017/08/20 13:04:38 |
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Basic information
Public title
Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia
Acronym
Phase II study of Pemetrexed + Carboplatin for lung cancer with interstitial pneumonia
Scientific Title
Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia
Scientific Title:Acronym
Phase II study of Pemetrexed + Carboplatin for lung cancer with interstitial pneumonia
Region
| Japan |
Condition
Condition
no-small and non-squamous lung cancer with interstitial penumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of carboplatin and pemetrexed combination therapy for non-small and non-squamous lung cancer with interstitial pneumonia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The frequency of severe lung injury on 28 days after the last chemotherapy
Key secondary outcomes
Response rate, disease control rate, overall survival and progression free 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
Pemetrexed and carboplatin combination 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Non-small and non-squamous lung cancer
2) Stable idiopathic interstitial pneumonia confirmed by high resolution chest CT
3) No indication of radiation therapy and surgical resection
4) Chemotherapy naive patients
5) Age over 20 -79 years
6) ECOG Performance status 0-1
7) %FVC >= 66% and %DLCO >= 36% for each predictive values within a month of registration
8) Adequate organ function
9) Life expectancy > 3 months
10) Signed informed consent
Key exclusion criteria
1) Having uncontroled infection
2) Having a fever (more than 38 degrees
(Celsius))
3) Having past history of acute exacerbation of interstitial pneumonia
4) Progression of interstitial pneumonia on chest CT within 3 months
5) Over 21mg/day dose of predonisolone
6) Sarcoidosis and collagen vascular diseases
7) Having past history of drug-induced lung injury and radiation pnumonitis
8) Having severe complications
9) Active concomitant malignancy without evidence of recurrence within 5 years
10) Having an uncontrolable pleural effusion
11) Having allergy for pemetrexed or carboplatin
12) History of pregnancy or lactation
13) Decision of ineligibility by the attending physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Taniguchi |
Organization
Tosei General Hospital
Division name
Respiratory Medicine and Allergy
Zip code
Address
160 Nishioiwake-cho, Seto, Aichi
TEL
0561-82-5101
lung@tosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Shiraki |
Organization
Ogaki Municipal Hospital
Division name
Respiratory Medicine
Zip code
Address
4-86 Minaminokawa-cho, Ogaki, Gifu
TEL
0584-81-3341
Homepage URL
akira.shiraki@gmail.com
Sponsor or person
Institute
Central Japan Lung Study Group (CJLSG)
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group (CJLSG)
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
| 2013 | Year | 07 | Month | 31 | 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
| 2013 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012988
| 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 |
