Non-small-cell lung cancer, Bile duct cancer, Pancreatic cancer
Conditions
Interventions
Patients with cancer are randomized to gemcitabine diluted with saline or 5% glucose solution at the first time after enrollment. Furthermore, those who are treated with gemcitabine diluted with salin
Sponsors
Tohoku University Translational Research Center
Tohoku University Hospital, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The diagnosis of non-small cell lung cancer was confirmed with histological or cytological examination. However, the diagnosis of pancreatic cancer and bile duct cancer can be confirmed with clinical finding including radiological methods without histological or cytological diagnosis; (2) Scheduled chemotherapy with gemcitabine; (3) Good performance status: a performance status (PS) of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale; (4) Informed consent to receive chemotherapy with gemcitabine and enrollment into this study were obtained;
Exclusion criteria
Exclusion criteria: (1) Without active interstitial pneumonitis or uncontrollable lung fibrosis (2) No concurrent thoracic radiotherapy during chemotherapy; (3) Without uncontrollable infectious disease; (4) No severe complication including heart failure, renal insufficiency, liver dysfunction, hemorrhagic digestive tract ulcer, ileus, and uncontrollable diabetic mellitus (5) Without pregnancy or nurse (6) No uncontrollable mental disease (7) No inappropriate patient judged by a medical doctor for enrollment into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and degree of vascular pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects equal to or more than Grade 2 in CTCAEv3.0 | — |
Countries
Japan
Contacts
Public ContactHiroki Nagai
Kyoto University Hospital Department of Respiratory Medicine
Outcome results
None listed