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Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075699
Recruitment Status : Completed
First Posted : January 13, 2004
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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 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 or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: cisplatin Drug: mitomycin C Drug: vincristine sulfate Drug: vinorelbine tartrate Procedure: pain therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Phase 3

Detailed Description:



  • 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 ASC and vinorelbine.


  • Compare the toxic effects of these regimens in these patients.
  • Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens.
  • Compare the performance status of patients treated with these regimens.
  • Compare analgesic usage in patients treated with these regimens.
  • Compare the tumor response and progression-free survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive active symptom control (ASC) through regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy, when required.
  • Arm II: Patients receive ASC and chemotherapy comprising mitomycin IV, vincristine IV, and cisplatin IV on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.
  • Arm III: Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks. Vinorelbine repeats every 55 days for a total of 2 courses.

Quality of life is assessed at baseline, every 3 weeks for 21 weeks, and then every 8 weeks thereafter.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma
Study Start Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks
  2. Performance status as measured by WHO grade
  3. Analgesic usage
  4. Toxicity as measured by the NCIC CTC
  5. Quality of life as assessed by the European Organization for Research and Treatment of Cancer
  6. Tumor response as measured by the RECIST criteria
  7. Progression-free survival as measured by CT scan

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • WBC > 3,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3


  • Not specified


  • Creatinine clearance > 50 mL/min


  • See Disease Characteristics


  • 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


Biologic therapy

  • Not specified


  • No prior chemotherapy for mesothelioma

Endocrine therapy

  • Not specified


  • Prior local radiotherapy to a wound site after exploratory thoracotomy allowed


  • See Disease Characteristics
  • See Radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00075699

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United Kingdom
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS1 3EX
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Medical Research Council
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Principal Investigator: Martin F. Muers, MD Leeds General Infirmary
Publications of Results:
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 Thoracic Society (BTS) MS01 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA7525, 390s, 2007.

Other Publications:
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.

Layout table for additonal information Identifier: NCT00075699    
Other Study ID Numbers: BTS-MRC-MS01
CDR0000347461 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 13, 2004    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: June 2008
Keywords provided by National Cancer Institute (NCI):
epithelial mesothelioma
localized malignant mesothelioma
advanced malignant mesothelioma
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors