UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010384 |
|---|---|
| Receipt number | R000012148 |
| Scientific Title | Predicting chemotherapy toxicity in elderly patients with non small cell lung cancer |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/04/05 20:35:50 |
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Basic information
Public title
Predicting chemotherapy toxicity in elderly patients with non small cell lung cancer
Acronym
Predicting elderly patients' vulnerability for chemotherapy
Scientific Title
Predicting chemotherapy toxicity in elderly patients with non small cell lung cancer
Scientific Title:Acronym
Predicting elderly patients' vulnerability for chemotherapy
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The goals of this study are to identify risk factors for chemotherapy toxicity in elderly patients and develop a risk stratification schema for chemotherapy toxicity.
Basic objectives2
Others
Basic objectives -Others
We want to develop a risk stratification schema for chemotherapy toxicity, and predict chemotherapy toxicity in elderly patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment for elderly patients; vulnerability for chemotherapy and incidence of toxicity
Key secondary outcomes
Assessment for compliance of chemotherapy, response rate and overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria are as follows: (1) pathologically proven non-small cell lung cancer adaptable to chemotherapy; (2)chemotherapy naive patients inadequate for operation and radiation therapy; (3) patients with aged 70 and over; (4) written informed consent.
Key exclusion criteria
Exclusin criteria are as follows: (1) patients with active other cancers; (2) patients treated with chemotherapy; (3)patients who needs thoracic radiotherapy; (4) patients who have pleural effusion with poor control; (5) Unsuitable cases are whom doctors jugde unable to be carried out this research safely, and who have severe dementia.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kanazu |
Organization
National Hospital Organization Toneyama Hospital
Division name
Department of Internal Medicine
Zip code
Address
5-1-1, toneyama, Toyonaka, Japan
TEL
06-6853-2001
kanamasa@toneyama.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Kanazu |
Organization
National Hospital Organization Toneyama Hospital
Division name
Department of Internal Medicine
Zip code
Address
5-1-1, toneyama, Toyonaka, Japan
TEL
06-6853-2001
Homepage URL
kanamasa@toneyama.go.jp
Sponsor or person
Institute
National Hospital Organization Kinki-chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients' characteristics, symptoms, clinical laboratory data, and activities of daily living are assessd at enrollment of study. Then, symptoms, clinical laboratory data, and clinical course are observed during medical treatments.
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2018 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012148
| 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 |
