Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
The purpose of this study is to test the safety of radiation therapy given at increased doses in a shorter period of time in order to find out what effects, good and/or bad, it has on the patient and the lung cancer. The standard way of giving the radiation therapy is to give it once daily for 6 to 7 weeks. The study is currently testing if a higher amount of radiation therapy per treatment can be given as well as shorten the total number of treatments to 4 or 5 weeks. The goal is that a higher dose of radiation therapy per treatment will be more effective than current standard treatments. In addition to the radiation treatment, patients will receive chemotherapy with carboplatin and paclitaxel, which are standard drugs for treating lung cancer.
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer|
- Maximum-tolerated RT dose fraction [ Time Frame: Up to 28 months ] [ Designated as safety issue: Yes ]
- Radiographic response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Metabolic response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Rates of progression: local/regional/distant [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Concurrent therapy + consolidation therapy
Concurrent Therapy (1 cycle = 14 days, Cycles 1-3): Patients will receive paclitaxel 45 mg/m^2 by IV over 1 hour weekly followed by carboplatin AUC 2 by IV over 30-60 minutes for 4 weeks (there will be no chemotherapy during Cycle 3). Patients will receive radiotherapy concurrently for up to 5.5 weeks, depending on the cohorts the patient is registered defined per the protocol.
Consolidation Therapy (1 cycle = 21 days, Cycles 4-5): Four weeks following the end of radiotherapy patients will receive paclitaxel 200 mg/m^2 by IV over 3 hours followed by carboplatin AUC 6 by IV over 30-60 minutes on day 1 of each 21 day cycle for a total of 2 cycles (days 1 and 22).
IVRadiation: radiation therapy
Defined per the protocol
OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated radiotherapy. Protocol therapy will consist of accelerated hypofractionated radiotherapy given with concurrent chemotherapy for two cycles. Consolidative chemotherapy will be given for two cycles after the completion of concurrent therapy. Patients will also receive premedications for paclitaxel as defined in the protocol.
- To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.
- To evaluate the rate of radiographic response to treatment.
- To estimate the rates of progression: local/regional/distant.
- To estimate the progression-free survival.
- To estimate the overall survival.
A maximum of 5 years follow up is required for all patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486602
|United States, Arizona|
|Mayo Clinic Hospital|
|Phoeniz, Arizona, United States, 85054|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|Moores University of California San Diego Cancer Center|
|La Jolla, California, United States, 92093-0987|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|State University of New York Upstate Medical University|
|Syracuse, New York, United States, 13210|
|United States, North Carolina|
|University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7305|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157-1030|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05401|
|Study Chair:||James J. Urbanic, MD||Wake Forest School of Medicine|