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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000735
Receipt No. R000000883
Scientific Title Phase II study of docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases
Date of disclosure of the study information 2007/06/07
Last modified on 2012/06/08

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Basic information
Public title Phase II study of docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases
Acronym Phase II study of docetaxel, cisplatin, and zoledronic acid for NSCLC
Scientific Title Phase II study of docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases
Scientific Title:Acronym Phase II study of docetaxel, cisplatin, and zoledronic acid for NSCLC
Region
Japan

Condition
Condition non-small cell lung cancer with bone metastases
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy in docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes feasibility
Key secondary outcomes response rate, skeletal-related event, overall 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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Zoledronic acid 4mg, day1
Docetaxel 60mg/m2, day1
Cisplatin 80mg/m2, day1
every 3 to 4 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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically, or cytologically proven non-small cell lung cancer
2. Stage IV with bone metastases
3. No prior chemotherapy for cancer
4. Measurable or evaluable disease
5. Age 20-75 years old
6. Performance status of 0-1
7. Adequate organ functions
8. Written informed consent
Key exclusion criteria 1. Emergency of radiotherapy to bone metastases
2. No prior bisphosphonates for cancer
3. Uncontrolled pleural or pericardial effusion
4. Symptomatic brain metastasis
5. Active infection
6. Severe odontopathy
7. Interstitial pneumonia/active lung fibrosis on chest x-ray
8. Active concomitant malignancy
9. Pregnant or lactating women
10. Severe drug-allergy
11. Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Nishiwaki, MD
Organization National Cancer Center Hospital East
Division name Thoracic Oncology Division
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL 04-7133-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyotaka Yoh, MD
Organization National Cancer Center Hospital East
Division name Thoracic Oncology Division
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email kyoh@east.ncc.go.jp

Sponsor
Institute Thoracic Oncology Division, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Thoracic Oncology Division, National Cancer Center Hospital East
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2007 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results The combination of Zoledronic Acid, cisplatin and docetaxel is well tolerated with acceptable renal toxicity and has modest activity as the first-line treatment of NSCLC patients with bone metastases.
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
2007 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2010 Year 12 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
2007 Year 06 Month 07 Day
Last modified on
2012 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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