UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036387 |
|---|---|
| Receipt number | R000025117 |
| Scientific Title | Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer |
| Date of disclosure of the study information | 2019/04/02 |
| Last modified on | 2020/10/02 22:59:06 |
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Basic information
Public title
Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Acronym
Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Scientific Title
Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Scientific Title:Acronym
Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Region
| Japan |
Condition
Condition
Squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum dose of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Basic objectives2
Others
Basic objectives -Others
determination of maximum dose and estimation of recommendation dose
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
determination of maximum dose and estimation of recommendation 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nedaplatin is administered on day 1 and S-1 is administered for 2 weeks (day 1 to 14).
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirmed squamous cell lung cancer.
2)stage III-IV without indication of curative radiotherapy and surgery, or relapsed case after surgery.
3)no more than 75 years-old
4)PS 0-1
Key exclusion criteria
1)Severe complication
2)interstitial penumonia
3)positive for HBs antigen
4)Pleural effusion, ascites, or pericardial effusion which need drainage
5)double malignancy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Kanaji |
Organization
Kagawa University
Division name
Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2145
kanaji@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Kanaji |
Organization
Kagawa University
Division name
Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2145
Homepage URL
kanaji@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
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
Kagawa University
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel
087-891-2345
chiken@med.kagawa-u.ac.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
| 2019 | Year | 04 | Month | 02 | 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
9
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
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025117
