Unique ID issued by UMIN | UMIN000018851 |
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Receipt number | R000021805 |
Scientific Title | A Pilot study of Chemotherapy with Human Atrial Natriuretic Peptie (hANP) as First-Line Treatment for Lung Cancer Patients. |
Date of disclosure of the study information | 2015/08/29 |
Last modified on | 2015/08/31 16:02:06 |
A Pilot study of Chemotherapy with Human Atrial Natriuretic Peptie (hANP) as First-Line Treatment for Lung Cancer Patients.
A Pilot study of chemotherapy with hANP for lung cancer patients
A Pilot study of Chemotherapy with Human Atrial Natriuretic Peptie (hANP) as First-Line Treatment for Lung Cancer Patients.
A Pilot study of chemotherapy with hANP for lung cancer patients
Japan |
The patients with histologically proven lung cancer
Pneumology |
Malignancy
NO
To investigate feasibility and efficacy of combination therapy of chemotherapy with hANP as first line therapy for lung cancer patients
Safety,Efficacy
The incidence of adverse events (acute renal injury or myelosuppression)
1. Response rate (RR)
2. Disease control rate (DCR)
3. Progression free survival (PFS)
4. Overall survival (OS)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
the combination therapy of chemotherapy with hANP
hANP administration (0.025µg/kg/min) is started at least 1day before the administration of chemotherapy. hANP administration is continued for 3 days, and performed each time of chemotherapy.
20 | years-old | <= |
Not applicable |
Male and Female
1. Histologically or cytologically proven lung cancer
2. Stage III/IV with unresectable or impossible of radical radiotherapy or postoperative recurrence
3. Chemotherapy naive
4. No radiation therapy for tumor in lung
5. BNP levels of 30pg/mL or more before treatment
6. Age: over 20
7. PS(ECOG): 0-1
8. Adequate organ functions judged by laboratory tests
9. Life expectancy: over 3 months
10. Written informed consent
1. Patient with active the other concurrent malignant diseases.
2. Symptomatic brain metastases
3. Therapy needed effusion (pleural or pericardial or ascites)
4. Interstitial pneumonitis or pneumonia
5. Uncontrollable infectious disease, autoimmune disease, or the other severe comorbidities.
6. Severe allergic history
7. History of right ventricular infarction
8. Severe hypotension
9. Severe hypovolemia
10. Women during pregnancy or breast-feeding
11. Other conditions judged ineligible by physician
20
1st name | |
Middle name | |
Last name | Masahide Mori/Yukihiro Yano |
National Hospital Organization Toneyama National Hospital
Department of Thoracic Oncology
Toneyama 5-1-1,Toyonaka City, Osaka 560-8552,Japan
06-6853-2001
honnnori2003@yahoo.co.jp
1st name | |
Middle name | |
Last name | Takashi Nojiri |
National Cerebral and Cardiovascular Center Research Institute
Department of Biochemistry
5-7-1, Fujishirodai, Suita-city, Osaka 565-8565
06-6833-5012
nojirit@thoracic.med.osaka-u.ac.jp
National Hospital Organization Toneyama National Hospital
None
Self funding
NO
国立病院機構刀根山病院
2015 | Year | 08 | Month | 29 | Day |
Unpublished
Open public recruiting
2015 | Year | 07 | Month | 31 | Day |
2015 | Year | 08 | Month | 01 | Day |
2015 | Year | 08 | Month | 29 | Day |
2015 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021805
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