Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Closed	18 and over	Other	BTS-MRC-MS01 ISRCTN54469112, EU-20349, NCT00075699

Objectives

Primary

1. 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.

Secondary

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

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC > 3,000/mm³
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³

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

Expected Enrollment

A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.

Outcomes

Overall survival

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

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

Muers MF, Stephens RJ, Fisher P, et al.: Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial. Lancet 371 (9625): 1685-94, 2008.[PUBMED Abstract]

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.

Muers MF, Rudd RM, O'Brien ME, et al.: BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112. Thorax 59 (2): 144-8, 2004.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Martin Muers, MD, Principal investigator		Ph: 44-113-243-2799

Registry Information
Official Title		A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients with Malignant Pleural Mesothelioma
Trial Start Date		2003-09-01
Registered in ClinicalTrials.gov		NCT00075699
Date Submitted to PDQ		2003-12-02
Information Last Verified		2008-06-04

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