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Mesothelioma Clinical Trials

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

This study is currently recruiting patients.

Sponsored by

British Thoracic Society
For more information:National Cancer Institute (NCI)

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: Randomizedphase III trial to compare the effectiveness of active symptom control with or without chemotherapy in treating patients who have malignant pleural mesothelioma.

Condition Treatment or Intervention
epithelial mesothelioma
localized malignant mesothelioma
advanced malignant mesothelioma
Drug: cisplatin
Drug: mitomycin
Drug: vincristine
Drug: vinorelbine
Procedure: chemotherapy
Procedure: pain therapy
Procedure: psychosocial assessment/care
Procedure: quality-of-life assessment
Procedure: supportive care/therapy

This is a Phase III test

  • In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. 

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Active Symptom Control With Versus Without Chemotherapy in Patients With Malignant Pleural Mesothelioma

Further Study Details: 


  • 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.

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 above,  Genders Eligible for Study:  Both



  • 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 

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