Unique ID issued by UMIN | UMIN000006935 |
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Receipt number | R000008197 |
Scientific Title | A phase II clinical trial of zoledronic acid treatment for advanced non-small cell lung cancer with bone metastasis. |
Date of disclosure of the study information | 2011/12/22 |
Last modified on | 2011/12/22 12:41:20 |
A phase II clinical trial of zoledronic acid treatment for advanced non-small cell lung cancer with bone metastasis.
A phase II clinical trial of zoledronic acid treatment for advanced non-small cell lung cancer with bone metastasis.
A phase II clinical trial of zoledronic acid treatment for advanced non-small cell lung cancer with bone metastasis.
A phase II clinical trial of zoledronic acid treatment for advanced non-small cell lung cancer with bone metastasis.
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the efficacy of zoledronic acid in non-small cell lung cancer patients with bone metastasis. To analyse the correlation between the efficacy and bone metabolic markers.
Safety,Efficacy
Phase II
Incidence of skeletal-related events(SRE)
1) Time to develop SRE
2) Incidence of adverse events
3) Progression free survival
4) Overall survival
5) Response rate
6) Rate of change in bone metabolic markers
7) Rate of change in pain score
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Zoledronic acid
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically comfirmed NSCLC
2)Patients have radiologically apparentbone metastasis
3)Aged >= 20
4)PS of 0-2
5)Adequate organ functions
6)Written informed consent
1)Hypersensitivity to zoledronic acid
2)Need of emergency treatment for bone metastasis by radiotherapy or surgery
3)Need of treatment for hypercalcemia
4)Prior use of bisphosphonates
5)Symptomatic brain metastasis
6)Active severe infections
7)Severe odontopathy
8)Interstitial pneumonia
9)Active concomitant malignancy
10) Pregnant or lactating
11)Uncontrolled heart disease, hepatic disease,diabetes mellitus, bleeding, etc.
12)Problematic phychiatric deasese
13)Inappropriate patients for this study judged by the physicians
40
1st name | |
Middle name | |
Last name | Yoshiki Ishii |
Dokkyo Medical University School of Medicine
Department of Pulmonary Medicine and Clinical Immunology,
880 Kitakobayashi, Mibu, Tochigi, Japan
0282-87-2151
1st name | |
Middle name | |
Last name |
Dokkyo Medical University School of Medicine
Department of Pulmonary Medicine and Clinical Immunology
0282-87-2151
ishiiysk@dokkyomed.ac.jp
Dokkyo Medical University School of Medicine, Department of Pulmonary Medicine and Clinical Immunology
Dokkyo Medical University School of Medicine, Department of Pulmonary Medicine and Clinical Immunology
Self funding
NO
獨協医科大学病院(栃木県)
2011 | Year | 12 | Month | 22 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2013 | Year | 07 | Month | 01 | Day |
2011 | Year | 12 | Month | 22 | Day |
2011 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008197
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