Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
|Lung Cancer||Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy||Phase 1|
|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 ]
- Radiographic response [ Time Frame: Up to 5 years ]
- Metabolic response [ Time Frame: Up to 5 years ]
- Rates of progression: local/regional/distant [ Time Frame: Up to 5 years ]
- Progression-free survival [ Time Frame: Up to 5 years ]
- Overall survival [ Time Frame: Up to 5 years ]
|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
I. To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.
I. To evaluate the rate of radiographic response to treatment. II. To estimate the rates of progression: local/regional/distant. III. To estimate the progression-free survival. IV. To estimate the overall survival.
OUTLINE: This is a dose-escalation study of accelerated hypofractionated radiotherapy.
CONCURRENT THERAPY: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4-5.5 weeks.
CONSOLIDATION THERAPY: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 2 years, and then every 6 months for 3 years.
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 University Health Sciences|