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Phase III Randomized Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma
Alternate Title Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
Objectives
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:
Cardiovascular:
Pulmonary:
Other:
Expected Enrollment A total of 240 patients will be accrued for this study over 24 months. Outline This is a randomized, open, multicenter study. Patients are stratified according to performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more). Patients are randomized to one of two treatment arms.
Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, prior to each course, after the last course, and then every 6 weeks for 1 year. Patients are followed every 6 weeks until death. Published ResultsBottomley A, Coens C, Efficace F, et al.: Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EORTC-NCIC 08983: randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol 25 (36): 5770-6, 2007.[PUBMED Abstract] Bottomley A, Gaafa R, Manegold C, et al.: Short-term treatment-related symptoms and quality of life: results from an international randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study. J Clin Oncol 24 (9): 1435-42, 2006.[PUBMED Abstract] van Meerbeeck JP, Gaafar R, Manegold C, et al.: Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol 23 (28): 6881-9, 2005.[PUBMED Abstract] Van Meerbeeck JP, Manegold C, Gaafar R, et al.: A randomized phase III study of cisplatin with or without raltitrexed in patients (pts) with malignant pleural mesothelioma (MPM): an intergroup study of the EORTC Lung Cancer Group and NCIC. [Abstract] J Clin Oncol 22 (Suppl 14): A-7021, 622s, 2004. Related PublicationsFrancart J, Legrand C, Sylvester R, et al.: Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma--The EORTC Lung Cancer Group. J Clin Oncol 24 (19): 3007-12, 2006.[PUBMED Abstract] Trial Lead Organizations 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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