UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003883 |
|---|---|
| Receipt number | R000004676 |
| Scientific Title | Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy. |
| Date of disclosure of the study information | 2010/07/07 |
| Last modified on | 2011/07/19 09:47:54 |
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Basic information
Public title
Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy.
Acronym
Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy.
Scientific Title
Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy.
Scientific Title:Acronym
Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy.
Region
| Japan |
Condition
Condition
relapsed squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of nedaplatin plus docetaxel in platinum-pretreated patients with squamous cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
overall survival, progression-free survival, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nedaplatin(80mg/m2/day) and Docetaxel(60mg/m2/day)on day1, 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) histologically or cytologically confirmed squamous cell lung cancer
2) received one prior chemotherapy or chemo-radiotherapy with platinum-based regimen
3) no prior treatment with nedaplatin or docetaxel
4) refractory or relapsed and measurable disease
5) performance status of 0-1 on the Eastern Cooperative Oncology Group scale
6) age from 20 to 74 years
7) adequate organ function
8) written informed consent
Key exclusion criteria
1) interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2) symptomatic brain metastasis
3) steroid treatment
4) massive pleural effusion or pericardial effusion
5) active infection
6) history of active double cancer
7) history of severe drug allergy
8) uncontrollable diabetes mellitus
9) HBs antigen
10) history of pregnancy or lactation
11) history of active psychological disease
12) severe drug allergy for 80 polysorbate content medicine
13) any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Yamamoto |
Organization
Shizuoka Cancer Center
Division name
Thoracic Oncology Division
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL
055-989-5222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruyasu Murakami |
Organization
Shizuoka Cancer Center
Division name
Shizuoka Cancer Center, Thoracic Oncology Division
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL
055-989-5222
Homepage URL
http://www.scchr.jp/
ha.murakami@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center, Thoracic Oncology Division
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
静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 07 | 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
| 2010 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 07 | Month | 07 | Day |
Last modified on
| 2011 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004676
