Status:
COMPLETED
Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
Lead Sponsor:
Medical Research Council
Conditions:
Malignant Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 contr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT00075699
Start Date
September 1 2003
Last Update
August 7 2013
Active Locations (3)
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1
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS1 3EX
2
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
3
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT