locally advanced non-small-cell lung cancer
Conditions
Interventions
take sodium alginate for start of therapy
take sodium alginate after symptom onset
take the water which cooled off to 4 degrees Celsius for start of therapy
Sponsors
Okayama Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed non-small-cell lung cancer Disease stage is IIIA/B period which is available for radical irradiation. ECOG performance status of 0 or 1 the case that we can ingest Adequate bone marrow function WBC 4,000/cmm or more; PLT 100,000/cmm or more Adequate liver function T Bil 1.5 mg/dl or less; GOT and GPT 2.5 times the upper limit of normal at each institution Adequate kidney function Creatinine 1.5 mg/dl or less; Ccr 60 ml/min or more Adequate pulmonary function Pa02 60 Torr or more However, this will not apply if there is reduced respiratory function due to stenosis of a main bronchus or a lobar bronchus, and it can be expected that resolution of the stenosis will lead to rapid improvement. Acquisition of written informed consent
Exclusion criteria
Exclusion criteria: the case that esophagus is not included in the fields in radiation treatment planning the case with atelectasis of the lung unilateral before treatment the case that has difficulty in oral internal use the case with serious complications the case that there is a history of treatment of esophageal cancer and the gastric cancer, and esophageal reconstruction is done the case with the reflux oesophagitis of the clear activity Pregnant woman, nursing mother, the women who may be pregnant, the women with the will or the men who hope for fertility with pregnancy the case that takes sodium alginate the case (when, however, it can be discontinued for condition possible registration) that takes proton pump inhibitor (PPI) regularly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Esophagitis incidence grade 3 or more based on CTCAE v4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| responce rate progression free survival overall survival Other adverse events Use ratio of analgesic quality of life | — |
Countries
Japan
Contacts
Public ContactKiichiro Ninomiya
Okayama University Hospital Department of Respiratory Medicine
Outcome results
None listed