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document
Multicenter randomized controlled trial of the management of unresectable malignant mesothelioma proposed by the British Thoracic Society and the British Medical Research Council . Malignant mesothelioma is almost invariably fatal . The incidence of the disease is rising rapidly in many countries , and there is no generally accepted standard treatment for patients with unresectable disease . According to current British Thoracic Society ( BTS ) guidelines , patients should be treated with active symptom control ( ASC ) , involving ( 1 ) regular follow-up in a specialist clinic ; ( 2 ) structured assessments of physical , psychological and social problems with appropriate action ; ( 3 ) rapid involvement of additional specialists ; and ( 4 ) parallel nursing support . Although many nonrandomized studies have reported tumor responses to anticancer chemotherapy , few have studied palliation and it is not known whether chemotherapy prolongs survival or provides clinically worthwhile palliation with acceptable toxicity when given in addition to ASC . We therefore plan to conduct a multicenter randomized controlled trial comparing ( 1 ) ASC alone , ( 2 ) ASC plus mitomycin vinblastine and cisplatin ( MVP ) , and ( 3 ) ASC plus vinorelbine ( N ; Navelbine , Pierre Fabre Oncology , Winchester , UK ) . We chose these chemotherapy regimens because they have been shown in nonrandomized studies to provide good symptom control as recorded by patients . The outcome measures are overall survival , palliation of symptoms , performance status , analgesic usage , toxicity , quality of life , tumor response , and recurrence/progression-free survival . In a preliminary feasibility study , we are assessing the acceptability of the trial design to patients and the suitability of two standard quality-of-life instruments in mesothelioma . Data will help us to decide the final details of the large multicenter trial .
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Intervention_Other
ASC alone
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Intervention_Pharmacological
ASC plus mitomycin vinblastine and cisplatin ( MVP )
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Intervention_Pharmacological
ASC plus vinorelbine
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Outcome_Mortality
overall survival
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Outcome_Physical
palliation of symptoms
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Outcome_Other
performance status
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Outcome_Pain
analgesic usage
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Outcome_Physical
toxicity
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Outcome_Other
quality of life
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Outcome_Physical
tumor response
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Outcome_Mortality
recurrence/progression-free survival
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Outcome_Other
quality-of-life
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Participant_Condition
management of unresectable malignant mesothelioma
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Participant_Condition
Malignant mesothelioma