Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
NCT ID: NCT00075699
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
840 participants
INTERVENTIONAL
2003-09-30
Brief Summary
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PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
mitomycin C
vincristine sulfate
vinorelbine tartrate
pain therapy
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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Martin F. Muers, MD
Role: PRINCIPAL_INVESTIGATOR
Leeds General Infirmary
Locations
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Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Countries
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References
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Muers MF, Rudd RM, O'Brien ME, Qian W, Hodson A, Parmar MK, Girling DJ; British Thoracic Society Mesothelioma Group. BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112. Thorax. 2004 Feb;59(2):144-8. doi: 10.1136/thorax.2003.009290.
Qian W, Muers MF, Rudd RM, et al.: A feasibility study of active symptom control (ASC) with or without chemotherapy in malignant pleural mesothelioma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2568, 639, 2003.
Muers MF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'Brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK; MS01 Trial Management Group. Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial. Lancet. 2008 May 17;371(9625):1685-94. doi: 10.1016/S0140-6736(08)60727-8.
Muers M, Fisher P, Snee M, et al.: A randomized phase III trial of active symptom control (ASC) with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma: first results of the Medical Research Council (MRC) / British Thoracic Society (BTS) MS01 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA7525, 390s, 2007.
Other Identifiers
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CDR0000347461
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN54469112
Identifier Type: -
Identifier Source: secondary_id
EU-20349
Identifier Type: -
Identifier Source: secondary_id
BTS-MRC-MS01
Identifier Type: -
Identifier Source: org_study_id