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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009993
Receipt No. R000011703
Scientific Title Phase I study on the feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer.
Date of disclosure of the study information 2013/02/18
Last modified on 2018/03/29

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Basic information
Public title Phase I study on the feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer.
Acronym Nedaplatin plus S-1 combination therapy for squamous cell lung cancer
Scientific Title Phase I study on the feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer.
Scientific Title:Acronym Nedaplatin plus S-1 combination therapy for 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 The feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer and dose of Nedaplatin are tested.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Determination of recommended dose of nedaplatin in the case of combination with S-1
Key secondary outcomes Safety, Drug adherence rate, response rate

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 plus S-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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patient who had squamous lung cancer, neither surgery nor radiation indication, accompanied by anti-cancer chemotherapy
2. Informed consent is obtained
3.Patient who is judged as an appropriate case by the doctor in charge
4. PS0-1
5. No history of cardiac failure, renal failure, or liver damage.
Key exclusion criteria 1. Patient who have severe infection
2. Pregnant or lactating women.
3. Multiple cancer
4. A known history of allergy
5. A known history of GI bleeding
6. Patient who have interstitial pneumonia
7. Patient who have severe diabetes mellitus, liver cirrhosis, renal dysfunction, angina pectoris, arrhythmia, or myocardiac infarction before 3 months
8. Patient who have therapeutic need of pleural effusion, pericardiac effusion, or SVC syndrome
9. Patient who have obscure symptoms of brain metastasis.
10. Patient who have obscure symptoms of peripheral nerve dysfunction
11. Patient who take flucytosin.of brain
12. Patient who have severe
13.patient who is judged as an inappropriate case by the doctor in charge
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Fujita
Organization Fukuoka University Hospital
Division name Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 092-801-1011
Email mfujita@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Fujita
Organization Fukuoka University Hospital
Division name Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 092-801-1011
Homepage URL
Email mfujita@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Department of Respiratory Medicine, Fukuoka University Hospital
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
Email

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 福岡大学病院(福岡県)
福岡大学筑紫病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 18 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
Because of shortage of case accumulation, the study was terminated.
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 Terminated
Date of protocol fixation
2013 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 07 Day
Last modified on
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011703

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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