Unique ID issued by UMIN | UMIN000001916 |
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Receipt number | 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 18:22:56 |
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).
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).
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).
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).
Japan |
Non-small cell carcinoma
Pneumology |
Malignancy
NO
To assess the efficacy of zoledronic acid in patients with bone metastases secondary to non-small cell lung cancer stratified by bone marker.
Efficacy
Confirmatory
Phase III
Time to first SRE(Skeletal Related Events)
SRE rate
Adverse events
Overall survival
Progression free survival
Treatment completion proportion
Response rate
Bone markers
Pain score
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
platinum based combination chemotherapy with Zoledronic acid
platinum based combination chemotherapy
20 | years-old | <= |
Not applicable |
Male and Female
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
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
160
1st name | |
Middle name | |
Last name | Masahiko Shibuya |
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division of Pulmonary Medicine
18-22, Honkomagome 3 chome, Bunkyo-ku, Tokyo 113-8677, JAPAN
03-3823-2101
1st name | |
Middle name | |
Last name | Yukio Hosomi |
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division of Pulmonary Medicine
18-22, Honkomagome 3 chome, Bunkyo-ku, Tokyo 113-8677, JAPAN
03-3823-2101
yhosomi@cick.jp
Thoracic Oncology Research Group (TORG)
None
Self funding
NO
2009 | Year | 05 | Month | 01 | Day |
Unpublished
Terminated
2008 | Year | 04 | Month | 02 | Day |
2008 | Year | 10 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2009 | Year | 04 | Month | 28 | Day |
2010 | Year | 04 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002331
Research Plan | |
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