UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003332 |
|---|---|
| Receipt number | 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 17:46:21 |
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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
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
naoki@z5.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine, division of Pulmonary Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004039
