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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009399
Receipt No. R000011036
Scientific Title Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer
Date of disclosure of the study information 2012/11/26
Last modified on 2012/11/26

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Basic information
Public title Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer
Acronym Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer
Scientific Title Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer
Scientific Title:Acronym Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer
Region
Japan

Condition
Condition Advanced Squamous Cell Lung Cancer
Classification by specialty
Pneumology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the toxicities and maximum tolerated dose (MTD) of nedaplatin with S-1, and to determine the recommended dose (RD) for Advanced Squamous Cell Lung Cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes To establish MTD and to determine the RD.
Key secondary outcomes safty,PFS,OS and RR.

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,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

Not applicable
Gender Male and Female
Key inclusion criteria Stage IIIB or IV squamous cell lung carcinoma
No indication of curable chemoradiation
Chemonaive
At least one measurable lesion
Age>20 years
Performance status of 0 to 1
Adequate main organ functions
WBC>3000/mm3
NET>1500/mm3
Plt>100000/mm3
Hb>9.0g/dl
T-bil<1.5mg/dl
GOT<100 IU/L, GPT<100IU/L
Creatinine<1.2mg/dL
Creatinine clearance>60mL/min
PaO2>60mmHg
No limitation of outpatients
Written informed consent
Key exclusion criteria History of active other malignancy
Severe heart disease
Severe complication
Intestinal pneumonia or lung fibrosis
Severe diarrhea
Massive pleural, cardiac, or abdominal effusion
Regular use of fenitoin, warfarin or frucitocin
Symptomatic brain metastasis
History of severe drug allergic reaction
Pregnant women or women willing child bearing
Inadequate condition diagnosed by primary physician
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isamu Okamoto
Organization Kinki University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Medical Oncology, Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Medical Oncology, Kinki University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 26 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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 26 Day
Last follow-up date
2017 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 26 Day
Last modified on
2012 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011036

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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