UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008872 |
|---|---|
| Receipt number | R000010416 |
| Scientific Title | Phase II study of Paclitaxel and Nedaplatin for previously untreated patients with advanced squamous cell lung cancer. |
| Date of disclosure of the study information | 2012/09/06 |
| Last modified on | 2016/02/26 17:06:22 |
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Basic information
Public title
Phase II study of Paclitaxel and Nedaplatin for previously untreated patients with advanced squamous cell lung cancer.
Acronym
Phase II study of Paclitaxel and Nedaplatin for previously untreated patients with advanced squamous cell lung cancer.
Scientific Title
Phase II study of Paclitaxel and Nedaplatin for previously untreated patients with advanced squamous cell lung cancer.
Scientific Title:Acronym
Phase II study of Paclitaxel and Nedaplatin for previously untreated patients with advanced squamous cell lung cancer.
Region
| Japan |
Condition
Condition
Squamous cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the combination of Paclitaxel and Nedaplatin for previously untreated patients with advanced squamous cell lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Paclitaxel+Nedaplatin
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.Histologically confirmed Stage IIIB/IV squamous cell lung cancer.
2.Previously untreated patients with chemotherapy.
3.With one or more measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1.
4.Age20<=
5.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
6.Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function.
7.A life expectancy of more than 3 months.
8.All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria
1.Symptomatic Brain metastasis.
2.History of active double cancer.
3.Severe infection.
4.Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc)
5.Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
6.With a history of drug sensitivity.
7.Pregnant or lactating women or those who declined contraception.
8.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Mori |
Organization
Tochigi Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
4-9-13 Yonan, Utsunomiya City, Tochigi, 320-0834
TEL
028-658-5151
takasai@tcc.pref.tochigi.lg.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kasai |
Organization
Tochigi Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
4-9-13, Yonan, Utsunomiya
TEL
028-658-5151
Homepage URL
takasai@tcc.pref.tochigi.lg.jp
Sponsor or person
Institute
Tochigi 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 | 09 | Month | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2016 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010416
