Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
- Determine the maximum tolerated course of accelerated 3-dimensional conformal
radiotherapy in patients with stage I non-small cell lung cancer with pulmonary
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients
treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment
pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week
for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy
until the maximum tolerated course is determined. The maximum tolerated course is defined as
the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity
and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then
every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 8-32 patients will be accrued for this study within 2-3
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Jeffrey A. Bogart, MD
State University of New York - Upstate Medical University
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.||Syracuse, New York 13217|
|Veterans Affairs Medical Center - Buffalo||Buffalo, New York 14215|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Fairview University Medical Center - University Campus||Minneapolis, Minnesota 55455|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Memorial Cancer Institute at Memorial Regional Hospital||Hollywood, Florida 33021|
|Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital||Fort Lauderdale, Florida 33308|
|Ella Milbank Foshay Cancer Center at Jupiter Medical Center||Jupiter, Florida 33458|
|Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center||Grand Island, Nebraska 68803|
|Great Plains Regional Medical Center||North Platte, Nebraska 69101-6598|
|Oswego Hospital||Oswego, New York 13126|
|Saint Luke's Hospital||Chesterfield, Missouri 63017|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital||Pittsburgh, Pennsylvania 15224-1791|
|St. Joseph's Hospital Health Center - Syracuse||Syracuse, New York 13203|