Locally Advanced Non-Small-Cell Lung Cancer
Conditions
Interventions
The phase I study was conducted to ascertain a recommended paclitaxel dosage. In the early part, chemotherapy consisted of paclitaxel (designated dosage) on days 1, 8, 15, 29, 36, and 43, and carbopla
Sponsors
Kansai Clinical Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Unresectable Locally Advanced Non-Small-Cell Lung Cancer Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 age more than 20 years, less 75 years leucocytes more than 4,000/mm3, neutrocytes more than 2,000/mm3, platelets more than 100,000/mm3, haemoglobin more than 9.0 g/dL, serum creatinine less than 1.5 mg/dl, AST and ALT less than twice upper limit of normal, partial pressure of arterial oxygen greater than 70 mmHg, and no abnormality found from echocardiographic examination.
Exclusion criteria
Exclusion criteria: pulmonary fibrosis requiring oxygen therapy, myocardial infarction that occurred during the prior six months, liver cirrhosis, active haemorrhage of the digestive tract, mental disorder requiring treatment, diabetes mellitus in poor control, paresis of the intestine ileus, active infection, case with a history of radiation in the fields of radiation, allergy to polyoxyethylene component preparation, peripheral neuropathy, and pregnancy. Cases that a physician judged to be inadequate were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of the phase I study was to determine a recommended dosage of paclitaxel during the concurrent chemoradiotherapy part. The primary endpoint of the phase II study was the response rate. Secondary endpoints were progression free survival, overall survival, and safety. | — |
Countries
Japan
Contacts
Public ContactMotonari Fukui
Tazuke Kofukai Medical Institute Kitano Hospital Respiratory Disease Center
Outcome results
None listed