Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01411098|
Recruitment Status : Terminated (Low accrual)
First Posted : August 8, 2011
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2015|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|