UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009399 |
|---|---|
| Receipt number | 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 11:16:31 |
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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
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
Sponsor or person
Institute
Department of Medical Oncology, Kinki University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011036
