The patients with histologically proven lung cancer
Conditions
Interventions
the combination therapy of chemotherapy with hANP hANP administration (0.025&
micro
g/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.
Sponsors
National Hospital Organization Toneyama National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (acute renal injury or myelosuppression) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate (RR) 2. Disease control rate (DCR) 3. Progression free survival (PFS) 4. Overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactTakashi Nojiri
National Cerebral and Cardiovascular Center Research Institute Department of Biochemistry
Outcome results
None listed