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Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Clinical research trials and Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma. Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma clinical trial. Human subjects often get the best healthcare available for their Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma  Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
For Condition: localized malignant mesothelioma,epithelial mesothelioma,advanced malignant mesothelioma
Status: Recruiting
Sponsor(s): British Thoracic Society ,
Synopsis: RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy. PURPOSE: Randomizedphase III trial to compare the effectiveness of active symptom control with or without chemotherapy in treating patients who have malignant pleural mesothelioma.
Details: 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. PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinMuers, Principal Investigator, Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Robin Rudd 44-20-7377-7000
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Mary O'Brien 44-20-8642-6011
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS1 3EX
United Kingdom
Recruiting Martin Muers 44-113-243-2799
Additional Information:
Study ID Numbers: CDR0000347461; EU-20349,ISRCTN-54469112,BTS-MRC-MS01
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075699
Other Advanced Malignant Mesothelioma Studies:
1. Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
2. Capecitabine in Treating Patients With Malignant Mesothelioma
3. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
4. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
5. Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
Related Studies:
Other advanced malignant mesothelioma Clinical Trials
Other England Clinical Trials
Other Sutton Clinical Trials
Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
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