|
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer Clinical research trials and Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer. Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer clinical trial. Participants frequently get the best healthcare available for their Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer  Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
For Condition: stage 2 non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 1 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 0 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare surgery with or without preoperative chemotherapy in treating patients who have resectable non-small cell lung cancer.
Details: OBJECTIVES: Primary - Compare the survival following surgical resection with or without preoperative chemotherapy for patients with resectable non-small cell lung cancer. Secondary - Compare the quality of life of patients treated with these regimens. - Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens. - Compare resectability rates in patients treated with these regimens. - Compare time to and site of relapse in patients treated with these regimens. - Determine response in patients treated with preoperative chemotherapy. - Determine the adverse effects of preoperative chemotherapy in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo surgical resection no more than 4 weeks after randomization. - Patients receive one of the following chemotherapy regimens immediately following randomization. - Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1. - Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1. - Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8. - Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1. - Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1. - Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy. Quality of life is assessed at 6 and 12 months, then annually thereafter. Patients are followed 1 month after surgery, 6 months after randomization, then every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 450-1,000 patients (225-500 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven, previously untreated, resectable non-small cell lung cancer - No evidence of distant metastases PATIENT CHARACTERISTICS: Age: - Any age Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Not specified Renal: - Not specified Other: - Considered fit for chemotherapy and surgical resection - No other disease or prior malignancy that would interfere with treatments - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis) - No concurrent immunotherapy Chemotherapy: - Not specified Endocrine therapy: - No concurrent hormonal agents, except corticosteroids Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AdrianHodson, Study Chair, Medical Research Council
Medical Research Council Clinical Trials Unit *Recruiting*
London, England, NW1 2DA
United Kingdom
Recruiting Adrian Hodson 44-20-7670-4735
Additional Information:
Study ID Numbers: CDR0000065952; MRC-LU22,EU-97016,ISRCTN25582437
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003159
Other Stage 0 Non-Small Cell Lung Cancer Studies:
1. Photodynamic Therapy With HPPH in Treating Patients With Early Stage Lung Cancer
2. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
3. Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
4. Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 0 non-small cell lung cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
|
|
|
|
|
|
|
|
