UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007120 |
|---|---|
| Receipt number | R000008384 |
| Scientific Title | A Prospective Single-center dose escalation study on the Safety of Lactoferin for post-treated advanced & recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2012/01/23 |
| Last modified on | 2013/11/18 12:50:03 |
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Basic information
Public title
A Prospective Single-center dose escalation study on the Safety of Lactoferin for post-treated advanced & recurrent non-small cell lung cancer
Acronym
A Prospective Single-center dose escalation study on the Safety of Lactoferin for post-treated advanced & recurrent non-small cell lung cancer
Scientific Title
A Prospective Single-center dose escalation study on the Safety of Lactoferin for post-treated advanced & recurrent non-small cell lung cancer
Scientific Title:Acronym
A Prospective Single-center dose escalation study on the Safety of Lactoferin for post-treated advanced & recurrent non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended dose (RD) of TS-1 and Lactoferin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
RD : Recommended Dose
Key secondary outcomes
Safety,Efficacy,Immunological response,QOL
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 | Food |
Interventions/Control_1
1)lactferin is administered orally.
Level 1 lactoferin 1g/day
Level 2 lactoferin 2g/day
Level 3 lactoferin 3g/day
2)TS-1 80mg/m2/day is administered orally for 2 consecutive weeks 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
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically confirmed unresectable non-small cell lung cancer, previous 2- regimen chemotherapy
2)Presence of at least one measurable lesion
3)ECOG Performance status 0-2
4)Life expectancy more than 3 months
5)Age: 20-84 years old
6)preserved organ's function
Hb>=9g/d
WBC>=3,000/mm3
Neutro>=1,500/mm3
Plt>=100,000/mm3
Total serum bilirubin <=1.5 mg/dl
GOT/GPT,ALP <=2xULNmg/dl
Serum creatinine <=1xULNmg/dl
Ccr>=50ml/min
7)Acquisition of written informed consent
Key exclusion criteria
1)pulmonary fibrosis or interstitial pneumonitis evident
2)Massive pleural effusion, pericardial effusion,and abdominal effusion
3)Simultaneous or metachronous double cancers
4)serious complications below
a)myocardial infarction within 6 months
b)Uncontrolled diabetes or hypertension
c)Current severe infection, or suspicious of severe
infection
d)History of serious drug allergic reaction
e)Massive effusion or edema
f)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
5)Symptomatic brain metastasis
6)now pregnant or lactation
7)History of radiation therapy or operation for lung cancer within 28 days at the time of entry.
8)History of unapproved drugs within 28 days at the time of entry.
9)Participation in this study before
10)History of serious allergic reaction with S-1
11)Being treated with other pyrimidine fluoride antineoplastic agents.
12)Being treated with flucytosine.
13)Wattery diarrhea
14)lactose intolerance
15)difficult to perform or continue of this study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Tsuboi |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
1-1-2, Nakao, Asahi-ku, Yokohama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
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 | 01 | Month | 23 | 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
| 2011 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 23 | Day |
Last modified on
| 2013 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008384
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
