Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Medical Research Council |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075699 |
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.
Condition | Intervention | Phase |
---|---|---|
Malignant Mesothelioma |
Drug: cisplatin Drug: mitomycin C Drug: vincristine sulfate Drug: vinorelbine ditartrate Procedure: pain therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma |
Estimated Enrollment: | 840 |
Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically and immunohistochemically confirmed malignant pleural mesothelioma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United Kingdom, England | |
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust | |
Leeds, England, United Kingdom, LS1 3EX | |
Royal Marsden NHS Foundation Trust - Surrey | |
Sutton, England, United Kingdom, SM2 5PT | |
Saint Bartholomew's Hospital | |
London, England, United Kingdom, EC1A 7BE |
Principal Investigator: | Martin F. Muers, MD | Leeds General Infirmary |
Study ID Numbers: | CDR0000347461, BTS-MRC-MS01, ISRCTN54469112, EU-20349 |
Study First Received: | January 9, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00075699 History of Changes |
Health Authority: | United States: Federal Government |
epithelial mesothelioma localized malignant mesothelioma advanced malignant mesothelioma |
Vincristine Vinblastine Antimitotic Agents Mitomycins Anti-Bacterial Agents Vinorelbine Cisplatin |
Mitomycin Tubulin Modulators Mesothelioma Antineoplastic Agents, Phytogenic Adenoma Alkylating Agents Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Mesothelial Mitosis Modulators Vincristine Vinblastine Enzyme Inhibitors Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions |
Neoplasms Vinorelbine Therapeutic Uses Tubulin Modulators Mitomycin Mesothelioma Antineoplastic Agents, Phytogenic Alkylating Agents Adenoma Nucleic Acid Synthesis Inhibitors Neoplasms, Glandular and Epithelial |