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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 14, 2002 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||
| Start Date ICMJE | November 2000 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00030459 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma | ||||||||
| Official Title ICMJE | Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||||||
| Condition ICMJE | Malignant Mesothelioma | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
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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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00030459 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000069167, BTS-MESO-1, MRC-BTS-MESO-1, EU-20134 | ||||||||
| Study Sponsor ICMJE | British Thoracic Society | ||||||||
| Collaborators ICMJE | Medical Research Council | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | May 2003 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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