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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001916
Receipt No. R000002331
Scientific Title Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).
Date of disclosure of the study information 2009/05/01
Last modified on 2010/04/28

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Basic information
Public title Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).
Acronym Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).
Scientific Title Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).
Scientific Title:Acronym Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).
Region
Japan

Condition
Condition Non-small cell carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of zoledronic acid in patients with bone metastases secondary to non-small cell lung cancer stratified by bone marker.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Time to first SRE(Skeletal Related Events)
Key secondary outcomes SRE rate
Adverse events
Overall survival
Progression free survival
Treatment completion proportion
Response rate
Bone markers
Pain score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 platinum based combination chemotherapy with Zoledronic acid
Interventions/Control_2 platinum based combination chemotherapy
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. Pathologically proven Non-small Cell Lung Cancer
2. At least 1 bone metastasis secondary to non-small cell lung cancer.
3. No prior chemotherapy.
4. More than 20 years of age
5. ECOG PS 0-2
6. Adequate organ function
7. Patients who have estimated life expectancy longer than 3 month
8. Signed informed consent
Key exclusion criteria 1. Sever allergy
2. Required radiation or operation for bone metastases
3. Hypercalcemia
4. History of using bisphosphonate
5. Massive pleural effusion, ascites and pericardial effusion required drainage
6. Symptomatic brain metastasis
7. Patients with serious infections or suspected infections
8. Patients who need dental treatment
9. Active ineterstitial pneumonitis
10. Active concomitant malignancy
11. Pregnant or lactating women
12. Acute Myocardial Infarction within 6 months.
13. Patinets with uncontroled complications
14. Psychological symptoms not suitable for this study
15. other conditions not suitable for this study
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Shibuya
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Division of Pulmonary Medicine
Zip code
Address 18-22, Honkomagome 3 chome, Bunkyo-ku, Tokyo 113-8677, JAPAN
TEL 03-3823-2101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Hosomi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Division of Pulmonary Medicine
Zip code
Address 18-22, Honkomagome 3 chome, Bunkyo-ku, Tokyo 113-8677, JAPAN
TEL 03-3823-2101
Homepage URL
Email yhosomi@cick.jp

Sponsor
Institute Thoracic Oncology Research Group (TORG)
Institute
Department

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
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
2009 Year 05 Month 01 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 Terminated
Date of protocol fixation
2008 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2011 Year 05 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
2009 Year 04 Month 28 Day
Last modified on
2010 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002331

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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