UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000735 |
|---|---|
| Receipt number | 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 18:49:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kyoh@east.ncc.go.jp
Sponsor or person
Institute
Thoracic Oncology Division, National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.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 |
