Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
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Trial Identification
Brief Title: Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Official Title: Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
Study ID: NCT00009789
Conditions
Interventions
Study Description
Brief Summary: 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. PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Detailed Description: OBJECTIVES: * Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction. * 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center, Grand Island, Nebraska, United States
Great Plains Regional Medical Center, North Platte, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Oswego Hospital, Oswego, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
St. Joseph's Hospital Health Center - Syracuse, Syracuse, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Contact Details
Name: Jeffrey Bogart, MD
Affiliation: State University of New York - Upstate Medical University
Role: STUDY_CHAIR
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