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Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer 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 Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer Clinical research trials and Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer 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 Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer. Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer 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 Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer 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 > "D" Clinical Trials Conditions > Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer  Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
For Condition: stage 1 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors plan better treatment for non-small cell lung cancer. PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated.
Details: OBJECTIVES: I. Determine whether the presence of occult micrometastases (OM) detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR) in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer. II. Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry (staining for cytokeratins and the CEA glycoprotein) or RT-PCR (to detect CEA mRNA)in these patients. III. Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients. IV. Determine the relationship between tumor size (or T-stage) and the presence of OM detected by immunohistochemistry or RT-PCR in these patients. V. Determine the relationship between the presence of OM and disease-free survival in these patients. VI. Determine the relationship between the site of OM and incidence of recurrence, site of recurrence, and survival of these patients. PROTOCOL OUTLINE: At the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 3-3.5 years.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Suspected or histologically confirmed previously untreated non-small cell lung cancer - Clinical stage I disease (*T1 or T2 primary *N1 or N2 lymph nodes less than 1 cm on CT scan or negative mediastinoscopy) Planned thoracotomy for lobectomy or pneumonectomy - Video-assisted lobectomy is acceptable if no preliminary wedge resection of tumor is performed No history of prior lung cancer --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: - At least 5 years since prior radiotherapy - No prior mediastinal or chest radiotherapy Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: - No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelMaddaus, Study Chair, Cancer and Leukemia Group B
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000065576; CLB-9761
Study Start Date: May 1997
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003006
Other Stage 1 Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
2. A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery
3. Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer
4. Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
5. Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
Related Studies:
Other stage 1 non-small cell lung cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
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