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Phase III Randomized Study of Surgery With or Without Preoperative Chemotherapy in Patients With Resectable Non-Small Cell Lung Cancer
Alternate Title Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Expected Enrollment 600A total of 600 patients (300 per treatment arm) will be accrued for this study. Outcomes Primary Outcome(s)Survival Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter Outline This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at 6 and 12 months and then annually thereafter. Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter. Published ResultsGilligan D, Nicolson M, Smith I, et al.: Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet 369 (9577): 1929-37, 2007.[PUBMED Abstract] Hopwood P, Nankivell M, Pugh C, et al.: Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9020, 498s, 2007. Nicolson M, Gilligan D, Smith I, et al.: Pre-operative chemotherapy in patients with resectable non-small cell lung cancer (NSCLC): first results of the MRC LU22/NVALT/EORTC 08012 multi-centre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7518, 389s, 2007. Trial Lead Organizations Medical Research Council Clinical Trials Unit
European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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