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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000069167 | Registry Identifier | PDQ (Physician Data Query) | |
| MRC-BTS-MESO-1 | |||
| EU-20134 |
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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably. It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma.
PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms.
Quality of life is assessed at baseline for all patients; at weeks 3, 6, 9, and 12 for arm I; at weeks 4, 7, 10, and 13 for arm II; at weeks 3, 6, 10, and 13 for arm III; at weeks 21 and 29, and then every 8 weeks thereafter for all patients.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| mitomycin C | Drug | |||
| vinblastine sulfate | Drug | |||
| vinorelbine tartrate | Drug |
DISEASE CHARACTERISTICS:
Immunohistochemically or cytologically confirmed malignant mesothelioma
Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy
Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Martin F. Muers, MD | Leeds General Infirmary | Study Chair |
| David J. Girling, MD | Medical Research Council | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Royal Hospital | Hull | England | HU8 9HE | United Kingdom | ||
| Leeds Teaching Hospital Trust |
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| Leeds |
| England |
| LS1 3EX |
| United Kingdom |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| Medical Research Council Clinical Trials Unit | London | England | NW1 2DA | United Kingdom |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Stobhill General Hospital | Glasgow | Scotland | G21 3UW | United Kingdom |
| Dorothy House Foundation | Bradford-Onavon | BA15 2LE | United Kingdom |
| St. Peters Hospital | Chertsey Surrey | KT 16 OPZ | United Kingdom |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016685 | Mitomycin |
| D014747 | Vinblastine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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