Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving specialized radiation therapy together with chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial studies the side effects and the best dose of specialized radiation therapy giving together with chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Radiation: 3-dimensional conformal radiation therapy
Radiation: hypofractionated radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||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 [ Designated as safety issue: No ]
- Radiographic response [ Designated as safety issue: No ]
- Metabolic response [ Designated as safety issue: No ]
- Rates of progression: local/regional/distant [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
- 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.
OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated radiotherapy.
Concurrent therapy: Patients receive paclitaxel IV over 60 minutes 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 to 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 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||Recruiting|
|Phoeniz, Arizona, United States, 85054|
|Contact: Steven E. Schild, MD 507-538-1760|
|Mayo Clinic Scottsdale||Recruiting|
|Scottsdale, Arizona, United States, 85259-5499|
|Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623|
|United States, California|
|Rebecca and John Moores UCSD Cancer Center||Recruiting|
|La Jolla, California, United States, 92093-0658|
|Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 email@example.com|
|United States, Illinois|
|University of Chicago Cancer Research Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424|
|United States, New York|
|SUNY Upstate Medical University Hospital||Recruiting|
|Syracuse, New York, United States, 13210|
|Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432|
|Wake Forest University Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771|
|Principal Investigator:||James J. Urbanic, MD||Comprehensive Cancer Center of Wake Forest University|