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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003332
Receipt No. R000004039
Scientific Title Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.
Date of disclosure of the study information 2010/03/15
Last modified on 2015/07/31

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Basic information
Public title Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.
Acronym Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.
Scientific Title Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.
Scientific Title:Acronym Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.
Region
Japan

Condition
Condition advanced squamous cell lung carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy for combination chemotherapy of Nedaplatin and S-1 in patients with advanced squamous cell lung carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase I : DLT (Dose-Limiting Toxicity)
Phase II : RR (Response Rate)
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 Patients receive nedaplatin(80-100 mg/m2, day1) plus S-1(80-120 mg/day, day1-14) every 3 weeks.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Sufficient oral intake
2.Histologically or cytologically confirmed squamous cell or adenosquamous cell lung cancer. Stage III without any indications for radiotherapy or Stage IV.
3.Age: 20 years to less than 80 years.
4.Patients with no previous treatment ( chemotherapy or radiotherapy) for lung cancer. Incrude recurrent disease after surgery who have no prior chemoterapy.
5.Measurable by RECST(ver 1.1) criteria.
6.adequate bone marrow, liver, and renal functions
Hb > 9.0 g/dL-1
WBC > 3500-12,000 mm-3
neutro > 2,000 mm-3
Plt > 100,000 mm-3
T-Bil< 1.5x upper normal limit
AST(GOT), ALT(GPT)< 1.5x upper normal limit
creatinine clearance > 60 ml/min
Pao2 > 60mmHg or SpO2 > 90%
7.ECOG performance status of 0 or 1
8.a life expectancy of 12 weeks or more
9.Written informed consent
Key exclusion criteria 1.History of grave drug allergic reaction
2.Patients under treatment with phenytoin or flucytosine.
3.Serious complications (e.g. intestinal paralysis, intestinal obstruction, interstitial pneumonia or fibroid lung detectable on chest X-ray films
, poorly controlled diabetes, heart failure, renal failure, hepatic failure, or haemorrhagic peptic ulcer etc.).
Serious medical complications
4. History of poorly controlled pleural effusion,pericardial effusion and ascites .
5.Symptomatic brain metastasis
6.Patients with uncontrolled water diarrhea or chronic constipation.
7.Active double cancer. Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
8.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers.
9.Males that are currently attempting to produce a pregnancy.
10.Inadequate physical condition, as diagnosed by primary physician.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soejima Kenzo
Organization Keio University School of Medicine
Division name Division of Pulmonary medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-121
Email ksoejima@cpnet.med.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiko Naoki
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3793
Homepage URL
Email naoki@z5.keio.ac.jp

Sponsor
Institute Keio University School of Medicine, division of Pulmonary Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine, division of Pulmonary 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
2010 Year 03 Month 15 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 Terminated
Date of protocol fixation
2010 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 13 Day
Last modified on
2015 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004039

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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