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EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical research trials and EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer  EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 1 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue. PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung cancer.
Details: OBJECTIVES: - Assess the frequency and degree of hypoxia as measured by etanidazole derivative EF5 binding in patients with stage I, II, or III non-small cell lung cancer. - Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers and tissue markers of hypoxia in these patients. - Correlate hypoxia as measured by EF5 binding with tumor angiogenesis and apoptosis in these patients. - Correlate tumor perfusion with hypoxia in these patients. - Correlate tumor perfusion with microvessel density in tumor samples in these patients. - Determine the longevity of EF5 adducts in human lung tumors. OUTLINE: Patients are stratified according to disease stage (stage I or II vs stage III vs no stage I-III determined after pathologic staging). Within 24-48 hours prior to the planned surgical procedure, patients receive etanidazole derivative EF5 IV over 1-2.5 hours. Tumor hypoxia is then measured using an intraoperative Eppendorf needle electrode during surgical biopsy or resection. Tumor specimens are tested for EF5 binding using immunohistochemistry and flow cytometry. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed or suspected non-small cell lung cancer (NSCLC) - If there is no histological or cytological documentation of NSCLC, must have at least a 75% probability of having NSCLC - Stage I-III - Tumor mass of at least 1.5 cm in maximum diameter must be present on CT scan and must be included in the planned surgical biopsy or resection - Must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study drug administration - Able to hold breath for 27 seconds - No allergy to IV contrast dye - No history of grade III or IV peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelKelley, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michael Kelley 919-286-0411 ext. 7326
Additional Information:
Study ID Numbers: CDR0000069437; NCI-2310,DUMC-3479-02-2
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041028
Other Stage 1 Non-Small Cell Lung Cancer Studies:
1. EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
2. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
3. Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
4. 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
5. 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
Related Studies:
Other stage 1 non-small cell lung cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
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