Chemotherapy naive thoracic malignancy
Conditions
Interventions
Without diuretics administration
Sponsors
Nippon Medical School Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Thoracic malignancy 2)Patients who are eligible for combination chemotherapy with cisplatin (60 mg/m2 or more) (including combination therapy with immune checkpoint inhibitors and molecular target therapy drugs, and chemoradiotherapy) 3)Previously untreated with cisplatin-based chemotherapy 4)Patients aged 20 to 74 years 5)ECOG PS 0-1 6)WBC > 3000, Neu > 1500, Hb > 9g/dL, PLT > 100000, AST < 100IU/L, ALT < 100IU/L, T-Bil < 1.5mg/dL, SpO2 > 95% (room air) 7)Creatinine is below the upper limit normal range and creatinine clearance is 60mL/min or more 8)Patients with sufficient oral intake 9)Patients who have given written informed consent
Exclusion criteria
Exclusion criteria: 1)Severe recurrent laryngeal nerve palsy or mediastinal mass 2)Pericardial effusion, pleural effusion, or ascites, with accumulation of fluid to a degree that requires drainage 3)Symptomatic brain metastases 4)Spinal metastases requiring urgent radiation or surgical treatment 5)Heart failure, unstable angina, myocardial infarction, acute kidney disease(within the past 6 months) 6)Complicated by poorly controlled diabetes even with continuous insulin use 7)Active infection(excluding viral hepatitis) 8)Receiving continuous systemic steroid therapy 9)Psychosis or comorbid psychiatric symptoms 10)Deemed inappropriate by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who did not observe a Grade 2 or higher creatinine increase after the first cycle(defined as elevation in creatinine, CTCAE Ver. 5.0, based on the upper limit of the normal range (ULN) for serum creatinine at each institute) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The proportion of patients without grade 2 or higher creatinine increase at end of cycle 2)The number of chemotherapy cycles 3)Response rate 4)The proportion of adverse events | — |
Countries
Japan
Contacts
Public ContactTetsuya Wako
Nippon Medical School Hospital Department of Pharmacy Services
Outcome results
None listed