UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040926 |
|---|---|
| Receipt number | R000046732 |
| Scientific Title | Pem+RT PI/II for ENSqNSCLC |
| Date of disclosure of the study information | 2020/06/28 |
| Last modified on | 2020/06/28 16:01:12 |
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Basic information
Public title
Phase I,II study ofPemetrexed and Concurrent Radiotherapy for Previously Untreated Elderly Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer
Acronym
Pem+RT PI/II for ENSqNSCLC
Scientific Title
Pem+RT PI/II for ENSqNSCLC
Scientific Title:Acronym
Pem+RT PI/II for ENSqNSCLC
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial was to determine the optimal dose of pemetrexed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determination of maximum tolerated dose.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Thoracic Radiation Therapy (once daily for 5 consecutive days of each week, total dose 60 Gy)+ Pemetrexed (400mg/m2) treatment on days 1, 22 and every 3weeks
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
Aged 75 and over. Histologically and/or cytologically confirmed stage IIIA or IIIB NSqNSCLC, inoperable disease, no history of chemotherapy or RT, an Eastern Cooperative Oncology Group performance status (PS) of 0 or 1, a life expectancy of 12 weeks or longer, adequate organ function (a leukocyte count of 4000/uL and over, a neutrophil count of 2000/uL and over, a hemoglobin level of 10 g/dL and over, a platelet count of 100000/uL and over, a serum bilirubin level of 1.5 mg/dL and over, serum alanine aminotransferase and aspartate aminotransferase levels 2 and over times higher than the upper limit of normal, and a serum creatinine level of 1.5 mg/dL and over), and an oxyhemoglobin saturation (SpO2) level (as measured by pulse oximetry) of 95% and over (in room air). No other form of cancer and determined by a radiologist as able to undergo RT safely (V20 and over 35%)
Key exclusion criteria
T3N1 disease; having suffered a myocardial infarction within the previous three months; uncontrolled diabetes mellitus, an active infection, interstitial pneumonia (confirmed by chest X-ray), cerebrovascular disease, symptomatic pericardial effusion, symptomatic superior vena cava syndrome, or a history of significant neurological or psychiatric disorders; severe heart disease, such as uncontrolled angina pectoris, heart failure, hyper- tension, or arrhythmia; positivity for the hepatitis B surface antigen; or any other complications that made the subject unsuitable for this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Takemoto |
Organization
Nagasaki University Hospital
Division name
Department of respiratory medicine
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki City
TEL
095-819-7273
shinnosuke-takemoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Takemoto |
Organization
Nagasaki University Hospital
Division name
Department of respiratory medicine
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki City
TEL
095-819-7273
Homepage URL
shinnosuke-takemoto@umin.ac.jp
Sponsor or person
Institute
Nagasaki University
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
Nagasaki University Hospital
Address
Sakamoto 1-7-1, Nagasaki City
Tel
095-819-7273
superprinking2@yahoo.co.jp
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
| 2020 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5668476/pdf/TCA-8-577.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5668476/pdf/TCA-8-577.pdf
Number of participants that the trial has enrolled
2
Results
Early termination because of 2 DLTs
Results date posted
| 2020 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
87 y.o female and 83y.o male
Participant flow
1st patient was 87 y.o female and 2nd patient was 83y.o male.
Adverse events
PEM was not administered to 1st patient because of not fulfilling the criteria. G5 pneumonitis was occurred in 2nd patient.
Outcome measures
Not evaluated
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | 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
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2020 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046732
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