Malignant Mesothelioma Clinical Trial
Official title:
A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma
Verified date | June 2008 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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: 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.
Status | Completed |
Enrollment | 840 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Medical Research Council |
United Kingdom,
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 Th
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. — View Citation
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 — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | No | ||
Secondary | Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks | No | ||
Secondary | Performance status as measured by WHO grade | No | ||
Secondary | Analgesic usage | No | ||
Secondary | Toxicity as measured by the NCIC CTC | Yes | ||
Secondary | Quality of life as assessed by the European Organization for Research and Treatment of Cancer | No | ||
Secondary | Tumor response as measured by the RECIST criteria | No | ||
Secondary | Progression-free survival as measured by CT scan | No |
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