UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005794 |
|---|---|
| Receipt number | R000006852 |
| Scientific Title | Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2011/06/20 |
| Last modified on | 2019/06/22 20:33:49 |
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Basic information
Public title
Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer
Acronym
Phase I/II trial of CBDCA+TS-1+RT in elderly patients with locally advanced NSCLC
Scientific Title
Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer
Scientific Title:Acronym
Phase I/II trial of CBDCA+TS-1+RT in elderly patients with locally advanced NSCLC
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine recommended dose, efficacy, and safety of carboplatin, TS-1, and concurrent radiation therapy in elderly patients with locally advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival rate at one year
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carboplatin, TS-1, and concurrent thoracic radiation 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
| 71 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologically diagnosed as non-small cell lung cancer
2) Unresectable locally advanced
3) Clinical stage III (UICC 7th edition)
4) Indication of radical thoracic radiation therapy
5) No prior chemotherapy or radiation therapy
6) Performance status 0-1
7) Age of 71 years or older
8) Adequate organ function
9) Life expectancy of at least 3 months
10) Written informed consent
Key exclusion criteria
1) Active concomitant malignancy
2) Infection, ileus, vomiting
3) Uncontrolled ulcer, diabetes mellitus
4) Interstitial pneumonia
5) Drug allergy
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ohe |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
yohe@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Niho |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
siniho@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Fund for cancer research
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
National Cancer Center Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2011 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
Main results already published
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 16 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006852
