UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000439 |
|---|---|
| Receipt number | R000000533 |
| Scientific Title | Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer |
| Date of disclosure of the study information | 2006/07/01 |
| Last modified on | 2010/11/04 10:11:16 |
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Basic information
Public title
Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Acronym
Phase1/2 study of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Scientific Title
Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Scientific Title:Acronym
Phase1/2 study of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Region
| Japan |
Condition
Condition
Preaviously untreated advanced advanced squamous cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of gemcitabine and nedaplatin in patients with previously untreated squamous cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Recommended dose
Dose limmiting toxicity
Response Rate
Key secondary outcomes
Overall survival
Time to progression
Toxicity
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
Combination chemotherapy with gemcitabine and nedaplation
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
1) Squamous cell lung cancer
2) Measurable lesions
3) Preaviously untreated advanced squamous cell lung cancer
4) PS(ECOG)0-1
5) Adequate organ fanctions
6) A life expectacy of at least 3 months
7) Written informed consent
Key exclusion criteria
1) Interstitial pneumonia or pulmonary fibrosis on chest X-P
2) peural or pericardial effusion requiring drainage
3) SVC syndrome
4) Symptomatic brain metastases
5) Active concominant malignancies
6) Uncontrolled diabetes mellitus or hypertension
7) Liver cirrhosis
8) Severe cardiovascular diseases
9) Pregnancy and lactation
10) Ccr<60ml/min
11) A history of serious drug allergy
12) Acute infection
13) Bleeding tendency
14) Unsuitable for entry to the study, decided by a medical oncologist
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Mio(Head),Katsuhiro Masago(Secretariat) |
Organization
Kyoto University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
54 Syogoin, Kawaramachi,Sakyo-Ku,Kyoto-City, Kyoto,Japan
TEL
075-751-3830
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Masago |
Organization
Kyoto unversity hospital
Division name
Department of Respiratory Medicine
Zip code
Address
54 Syogoin, Kawaramachi,Sakyo-Ku,Kyoto-City, Kyoto,Japan
TEL
075-751-3830
Homepage URL
mio@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine of Kyoto University Hospital
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
京都大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 07 | Month | 01 | 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
Date of protocol fixation
| 2006 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 06 | Month | 28 | Day |
Last modified on
| 2010 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000533
