A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma
Data Collection
Mesothelioma, Malignant+11
+ Adenoma
+ Lung Diseases
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control (ASC) alone vs ASC and mitomycin, vinblastine, and cisplatin vs ASC and vinorelbine. Secondary * Compare the toxic effects of these regimens in these patients. * Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens. * Compare the performance status of patients treated with these regimens. * Compare analgesic usage in patients treated with these regimens. * Compare the tumor response and progression-free survival of patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive active symptom control (ASC) through regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy, when required. * Arm II: Patients receive ASC and chemotherapy comprising mitomycin IV, vincristine IV, and cisplatin IV on day 1. Chemotherapy repeats every 21 days for a total of 4 courses. * Arm III: Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks. Vinorelbine repeats every 55 days for a total of 2 courses. Quality of life is assessed at baseline, every 3 weeks for 21 weeks, and then every 8 weeks thereafter. Patients are followed at 15, 18, and 21 weeks, and then every 8 weeks thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.840 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically and immunohistochemically confirmed malignant pleural mesothelioma * Epithelial and other histological types are allowed * No more than 3 months since diagnosis * Symptomatic pleural effusion must have been treated and brought under control by drainage, pleurodesis, or pleurectomy * Prior surgical resection of mesothelioma allowed provided 2 CT scans at least 6 weeks apart show stable or progressive disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Not specified Renal * Creatinine clearance \> 50 mL/min Pulmonary * See Disease Characteristics Other * Not pregnant or nursing * Fertile patients must use effective contraception * Considered medically fit to receive chemotherapy * No other disease or prior malignancy likely to interfere with protocol treatments or comparisons * No clinical evidence of infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for mesothelioma Endocrine therapy * Not specified Radiotherapy * Prior local radiotherapy to a wound site after exploratory thoracotomy allowed Surgery * See Disease Characteristics * See Radiotherapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Leeds, United KingdomOpen Leeds General Infirmary at Leeds Teaching Hospital NHS Trust in Google MapsSaint Bartholomew's Hospital
London, United KingdomRoyal Marsden NHS Foundation Trust - Surrey
Sutton, United Kingdom