UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001227 |
|---|---|
| Receipt number | R000001496 |
| Scientific Title | Phase I/II trial of Nedaplatin and Docetaxel for advanced Squamous cell carcinoma of the lung |
| Date of disclosure of the study information | 2008/07/07 |
| Last modified on | 2013/01/04 16:27:21 |
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Basic information
Public title
Phase I/II trial of Nedaplatin and Docetaxel for advanced Squamous cell carcinoma of the lung
Acronym
Phase I/II trial of Nedaplatin and Docetaxel for advanced Squamous cell carcinoma of the lung
Scientific Title
Phase I/II trial of Nedaplatin and Docetaxel for advanced Squamous cell carcinoma of the lung
Scientific Title:Acronym
Phase I/II trial of Nedaplatin and Docetaxel for advanced Squamous cell carcinoma of the lung
Region
| Japan |
Condition
Condition
chamotherapy-naive advanced squamous cell carcinoma of the lung
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended dose of nedaplatin and docetaxel
To evaluate the efficacy of nedaplatin and docetaxel at recommended dose
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Response rate (phase II study)
Key secondary outcomes
one year survival rate, overall survival, progression free survival, adverse event
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
combination chemotherapy of nedaplatin and docetaxel
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) histologically/cytologically proven squamous cell carcinoma of th lung
2) patients with stage III who are not candidate for definitive thoracic radiotherapy, patinets with stage IV, and patients with reccurent disease after surgery
3)chemothrapy naive
4)Measurable lesion according to RECIST guideline
5)ECOG PS 0-1
6)adequate organ function
7)Written informed consent
Key exclusion criteria
1)Pre-existing pulmonary fibrosis (chest Xray)
2)Previous history of another cancer
3)Uncontrolled comorbidities
4)Active infection
5)Pregnancy or lactation
6)Symptomatic brain metastases
7)Allergy to polysorbate 80
8)Considered unfit for trial by own physician
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Nishiwaki |
Organization
National Cancer Center Hospital East
Division name
Thoracic Oncology Division
Zip code
Address
6-5-1 Kashiwanoha Kashiwa Chiba Japan
TEL
0471-33-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Naito |
Organization
National Cancer Center Hospital East
Division name
Thoracic Oncology Division
Zip code
Address
6-5-1 Kashiwanoha Kashiwa Chiba Japan
TEL
0471-33-1111
Homepage URL
ynaito@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East 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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.2009worldlungcancer.org/
Number of participants that the trial has enrolled
Results
Thirteen patients (62%) out of 21 responded to nedaplatin and docetaxel. Median progression-free survival was 7.4 months (95% CI 3.5 – 11.4 months).
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
| 2006 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
One patients died of sepsis on the treatment day 9 at first cycle.
Management information
Registered date
| 2008 | Year | 07 | Month | 01 | Day |
Last modified on
| 2013 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001496
