Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
|Recurrent Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer||Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Drug: cisplatin Drug: etoposide||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Dose-Intensification Study Using Radiation Therapy and Concurrent Cisplatin and Etoposide for Patients With Inoperable Non-small Cell Lung Cancer|
- MTD of radiotherapy, in terms of number of daily fractions, that can be delivered using 3D-CRT or IMRT with the standard cisplatin/etoposide regimen [ Time Frame: Up to 8 weeks after completion of radiotherapy ]The MTD will be the highest dose at which no more than one of six patients experience a dose-limiting toxicity. Toxicity will be scored using the National Cancer Institute Common Toxicity Criteria version 4.0.
|Study Start Date:||October 2011|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (radiation therapy and chemotherapy)
Patients undergo 3D-CRT or IMRT 5 days a week for 8 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5, and 28-32.
Radiation: 3-dimensional conformal radiation therapy
Other Names:Radiation: intensity-modulated radiation therapy
Other Name: IMRTDrug: cisplatin
Other Names:Drug: etoposide
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 and 28-32.
After completion of study treatment, patients are followed up at 8 weeks and 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411098
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Shilpen Patel||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|