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Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction Clinical research trials and Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction. Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction clinical trial. Subjects typically recieve the finest healthcare available for their Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction  Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
For Condition: adenosquamous cell lung cancer,bronchoalveolar cell lung cancer,adenocarcinoma of the lung,large cell lung cancer,stage 1 non-small cell lung cancer,squamous cell lung cancer
Status: Suspended
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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 reached. 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 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC) - Squamous cell carcinoma - Basaloid carcinoma - Adenocarcinoma - Bronchoalveolar carcinoma - Adenosquamous carcinoma - Large cell carcinoma - Large cell neuroendocrine carcinoma - Giant cell carcinoma - Sarcomatoid carcinoma - Non-small cell carcinoma not otherwise specified - Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows) - No metastatic disease or hilar or mediastinal lymphadenopathy - Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan - No positive lymph nodes on mediastinoscopy NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum - Poor surgical risk as defined by 1 of the following: - High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy - Pulmonary dysfunction indicated by one or more of the following: - FEV_1 less than 40% of predicted - DLCO less than 50% of predicted - Oxygen dependent - Chronic PaCO_2 greater than 45 mm Hg - VO_2 less than 15 mL/kg/min PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - See Disease Characteristics Renal: - See Disease Characteristics Cardiovascular: - See Disease Characteristics Pulmonary: - See Disease Characteristics Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No weight loss of more than 10% within the past 6 months - No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for NSCLC Endocrine therapy: - Not specified Radiotherapy: - No prior chest radiotherapy Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyBogart, Study Chair, State University of New York
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: CDR0000068409; CALGB-39904
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009789
Other Squamous Cell Lung Cancer Studies:
1. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
2. Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
3. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
4. Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
5. Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
Related Studies:
Other squamous cell lung cancer Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
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