A Phase I Dose-intensification Study Using Radiation Therapy and Concurrent Cisplatin and Etoposide for Patients With Inoperable Non-small Cell Lung Cancer
I. To determine the maximum tolerated dose (MTD) of escalating doses of radiotherapy (RT)
administered concomitantly with a fixed dose of cisplatin and etoposide within the same
overall treatment time.
OUTLINE: This is a dose-escalation study of radiation therapy.
Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated
radiotherapy (IMRT) 5 days a week for 8 weeks. Patients also receive cisplatin intravenously
(IV) over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5
After completion of study treatment, patients are followed up at 8 weeks and 6 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of radiotherapy, in terms of number of daily fractions, that can be delivered using 3D-CRT or IMRT with the standard cisplatin/etoposide regimen
The MTD will be the highest dose at which no more than one of six patients experience a dose-limiting toxicity (DLT). Toxicity will be scored using the National Cancer Institute (NCI) Common Toxicity Criteria version 4.0.
Up to 8 weeks after completion of radiotherapy
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|